Trial Outcomes & Findings for Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy. (NCT NCT05419947)
NCT ID: NCT05419947
Last Updated: 2025-06-17
Results Overview
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Results posted on
2025-06-17
Participant Flow
The annual rate of LC in the two hospitals in the study is over 300 surgeries per year. In order to recruit 200 in both centres, a review waiting list will be conducted. Patients who meet the inclusion criteria will be given the necessary information and, after signing the informed consent form, will be included in the trial.
Screening details: Patients scheduled for laparoscopic cholecystectomy who meet all inclusion criteria and none of the exclusion criteria
Participant milestones
| Measure |
Fixed Dose 3 Hours
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
|
Fixed Dose 30 Min
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
|
Weight-adjusted Dose 3 Hour
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
|
Weight-adjusted Dose 30 Min
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
45
|
44
|
62
|
|
Overall Study
COMPLETED
|
47
|
45
|
44
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
Baseline characteristics by cohort
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Between 20 and 91 years
|
47 participants
n=47 Participants
|
45 participants
n=45 Participants
|
44 participants
n=44 Participants
|
60 participants
n=60 Participants
|
200 participants
n=196 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=47 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
25 Participants
n=45 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
25 Participants
n=44 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
38 Participants
n=60 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
121 Participants
n=196 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
|
Sex: Female, Male
Male
|
14 Participants
n=47 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
20 Participants
n=45 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
19 Participants
n=44 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
22 Participants
n=60 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
75 Participants
n=196 Participants • Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index (BMI)
|
30.5 Kilogram per square meter
STANDARD_DEVIATION 6.3 • n=47 Participants
|
27.1 Kilogram per square meter
STANDARD_DEVIATION 4.8 • n=45 Participants
|
28.9 Kilogram per square meter
STANDARD_DEVIATION 6.6 • n=44 Participants
|
28.4 Kilogram per square meter
STANDARD_DEVIATION 7.1 • n=60 Participants
|
27.9 Kilogram per square meter
STANDARD_DEVIATION 8.2 • n=196 Participants
|
PRIMARY outcome
Timeframe: During surgical procedure, before beginning the dissection of the hepatocystic triangle.Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Outcome measures
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
|---|---|---|---|---|
|
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Category 1
|
26 Participants
|
20 Participants
|
26 Participants
|
29 Participants
|
|
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Category 2
|
32 Participants
|
25 Participants
|
28 Participants
|
36 Participants
|
|
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Category 3
|
15 Participants
|
12 Participants
|
18 Participants
|
19 Participants
|
|
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Category 4
|
23 Participants
|
19 Participants
|
25 Participants
|
19 Participants
|
|
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Category 5
|
16 Participants
|
16 Participants
|
16 Participants
|
25 Participants
|
|
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Category 6
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During surgical procedure, after dissection of the hepatocystic triangle.Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Outcome measures
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
|---|---|---|---|---|
|
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Category 1
|
40 Participants
|
38 Participants
|
36 Participants
|
45 Participants
|
|
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Category 2
|
42 Participants
|
33 Participants
|
35 Participants
|
48 Participants
|
|
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Category 3
|
41 Participants
|
35 Participants
|
36 Participants
|
40 Participants
|
|
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Category 4
|
41 Participants
|
35 Participants
|
36 Participants
|
40 Participants
|
|
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Category 5
|
24 Participants
|
26 Participants
|
25 Participants
|
36 Participants
|
|
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Category 6
|
6 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During surgical procedure, before beginning the dissection of the hepatocystic triangle.Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Outcome measures
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
|---|---|---|---|---|
|
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
1=little
|
12 Participants
|
20 Participants
|
12 Participants
|
25 Participants
|
|
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
2=sufficient
|
11 Participants
|
7 Participants
|
4 Participants
|
11 Participants
|
|
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
3=quite a bit
|
6 Participants
|
5 Participants
|
9 Participants
|
3 Participants
|
|
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
4=good
|
11 Participants
|
7 Participants
|
10 Participants
|
13 Participants
|
|
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
5=excellent
|
7 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During surgical procedure, after the disection of the hepatocystic triangle has begun.Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Outcome measures
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
|---|---|---|---|---|
|
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
5= excellent
|
15 Participants
|
17 Participants
|
13 Participants
|
17 Participants
|
|
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
1=little
|
6 Participants
|
6 Participants
|
5 Participants
|
13 Participants
|
|
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
2=sufficient
|
6 Participants
|
12 Participants
|
6 Participants
|
10 Participants
|
|
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
3= quite a bit
|
8 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
4= good
|
12 Participants
|
6 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During surgical procedureExtent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Outcome measures
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
|---|---|---|---|---|
|
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
2= very useful
|
21 Participants
|
12 Participants
|
22 Participants
|
24 Participants
|
|
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
0= not useful
|
4 Participants
|
9 Participants
|
3 Participants
|
13 Participants
|
|
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
1= moderately useful
|
22 Participants
|
24 Participants
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: During surgical procedureExtent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Outcome measures
| Measure |
Fixed Dose 3 Hours
n=47 Participants
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Fixed Dose 30 Min
n=45 Participants
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 3 Hour
n=44 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
Weight-adjusted Dose 30 Min
n=60 Participants
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
VERDYE powder for solution for injection 25 mg: Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
|
|---|---|---|---|---|
|
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Cat 0
|
26 Participants
|
12 Participants
|
26 Participants
|
7 Participants
|
|
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Cat 1
|
16 Participants
|
17 Participants
|
13 Participants
|
20 Participants
|
|
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Cat 2
|
4 Participants
|
4 Participants
|
5 Participants
|
15 Participants
|
|
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Cat 3
|
1 Participants
|
9 Participants
|
0 Participants
|
9 Participants
|
|
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Cat 4
|
0 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
Adverse Events
Total Number of Patients
Serious events: 13 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total Number of Patients
n=196 participants at risk
All patients who completed the study, regardless of the group to which they were randomized. Adverse events were not analyzed separately by study arm but rather aggregated across all participants. Consequently, in the following sections, all references to adverse events pertain to this combined analysis. This approach was selected because the occurrence of adverse events is primarily related to the surgical intervention required for each patient's underlying pathology, rather than to the treatment arm to which the patient was randomized. Therefore, stratifying adverse events by study arm would not yield specific information regarding the dose or timing of administration of the investigational medicinal product.
|
|---|---|
|
Hepatobiliary disorders
Adenocarcinoma
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Cardiac disorders
Heart failure
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Immune system disorders
Hypersensitivity
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.51%
1/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Cholecystitis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Cholangitis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Abscess
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Intraabdominal fluid collection
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
Other adverse events
| Measure |
Total Number of Patients
n=196 participants at risk
All patients who completed the study, regardless of the group to which they were randomized. Adverse events were not analyzed separately by study arm but rather aggregated across all participants. Consequently, in the following sections, all references to adverse events pertain to this combined analysis. This approach was selected because the occurrence of adverse events is primarily related to the surgical intervention required for each patient's underlying pathology, rather than to the treatment arm to which the patient was randomized. Therefore, stratifying adverse events by study arm would not yield specific information regarding the dose or timing of administration of the investigational medicinal product.
|
|---|---|
|
Vascular disorders
Ecchymosis
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Vascular disorders
Phlebitis
|
1.5%
3/196 • Number of events 3 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Vascular disorders
Haematoma
|
1.5%
3/196 • Number of events 3 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Vascular disorders
Hypotension
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
General disorders
Pain
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
General disorders
Fever
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
General disorders
Pyrexia
|
2.0%
4/196 • Number of events 4 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Psychiatric disorders
Anxiety disorders
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Psychiatric disorders
Nervousness
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Injury, poisoning and procedural complications
Dehiscense
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Injury, poisoning and procedural complications
Accident
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Cardiac disorders
Sinus bradycardia
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Cardiac disorders
Tachycardia
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Nervous system disorders
Headache
|
2.0%
4/196 • Number of events 4 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Nervous system disorders
Disorientation
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Nervous system disorders
Paraesthesia
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Nervous system disorders
Somnolence
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Eye disorders
Vision blurred
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
5/196 • Number of events 5 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/196 • Number of events 3 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Melaena
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
14/196 • Number of events 14 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Skin and subcutaneous tissue disorders
Omphalitis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Renal and urinary disorders
Dysuria
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.51%
1/196 • Number of events 3 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Abcess
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Abcess intestinal
|
1.0%
2/196 • Number of events 2 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Conjunctivitis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
COVID-19
|
1.5%
3/196 • Number of events 3 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Infection
|
1.5%
3/196 • Number of events 3 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Infections and infestations
Fungal infection
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.51%
1/196 • Number of events 1 • The adverse event collection period in this study extends from the time of surgery until one month postsurgery.
Adverse and serious adverse events were defined per clinical trial guidelines. Events were analyzed collectively, as their occurrence depends on the surgical procedure for each patient's underlying pathology, not on the treatment arm.
|
Additional Information
Dr. Luis Muñoz Bellvís
Instituto de Investigación Biomédica de Salamanca (IBSAL)
Phone: 0034 923 29 11 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place