Trial Outcomes & Findings for Fluorescent Cholangiography vs White Light for Bile Ducts Identification (NCT NCT02702843)
NCT ID: NCT02702843
Last Updated: 2025-11-12
Results Overview
Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
677 participants
Primary outcome timeframe
Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure.
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Xenon Light
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
|
Near Infrared Light
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after a single injection of 5 cc of indocyanine green at least 30 minutes pre-operatively.
|
|---|---|---|
|
Overall Study
STARTED
|
333
|
344
|
|
Overall Study
COMPLETED
|
318
|
321
|
|
Overall Study
NOT COMPLETED
|
15
|
23
|
Reasons for withdrawal
| Measure |
Xenon Light
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
|
Near Infrared Light
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after a single injection of 5 cc of indocyanine green at least 30 minutes pre-operatively.
|
|---|---|---|
|
Overall Study
Insufficient data to analyze
|
15
|
23
|
Baseline Characteristics
Fluorescent Cholangiography vs White Light for Bile Ducts Identification
Baseline characteristics by cohort
| Measure |
Xenon Light
n=318 Participants
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
|
Near Infrared Light
n=321 Participants
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.
|
Total
n=639 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
261 Participants
n=10 Participants
|
264 Participants
n=10 Participants
|
525 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=10 Participants
|
57 Participants
n=10 Participants
|
114 Participants
n=20 Participants
|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 15.5 • n=10 Participants
|
48.3 years
STANDARD_DEVIATION 15.0 • n=10 Participants
|
48.4 years
STANDARD_DEVIATION 15.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=10 Participants
|
218 Participants
n=10 Participants
|
399 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=10 Participants
|
103 Participants
n=10 Participants
|
240 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
318 Participants
n=10 Participants
|
321 Participants
n=10 Participants
|
639 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
318 Participants
n=10 Participants
|
321 Participants
n=10 Participants
|
639 Participants
n=20 Participants
|
|
Region of Enrollment
Argentina
|
96 participants
n=10 Participants
|
104 participants
n=10 Participants
|
200 participants
n=20 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=10 Participants
|
74 participants
n=10 Participants
|
157 participants
n=20 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=10 Participants
|
1 participants
n=10 Participants
|
1 participants
n=20 Participants
|
|
Region of Enrollment
Italy
|
33 participants
n=10 Participants
|
31 participants
n=10 Participants
|
64 participants
n=20 Participants
|
|
Region of Enrollment
Germany
|
106 participants
n=10 Participants
|
111 participants
n=10 Participants
|
217 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure.Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification.
Outcome measures
| Measure |
Xenon Light
n=318 Participants
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
|
Near Infrared Light
n=321 Participants
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.
|
|---|---|---|
|
Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light
Before Dissection
|
64 Participants
|
157 Participants
|
|
Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light
After Dissection
|
159 Participants
|
243 Participants
|
Adverse Events
Xenon Light
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Near Infrared Light
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xenon Light
n=318 participants at risk
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
|
Near Infrared Light
n=321 participants at risk
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.
|
|---|---|---|
|
Hepatobiliary disorders
Bile Duct Injury
|
0.63%
2/318 • Number of events 2 • 1 year
|
0.00%
0/321 • 1 year
|
Other adverse events
| Measure |
Xenon Light
n=318 participants at risk
Laparoscopic cholecystectomy with Xenon Light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
|
Near Infrared Light
n=321 participants at risk
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.
|
|---|---|---|
|
Surgical and medical procedures
Conversion to Open
|
1.3%
4/318 • Number of events 4 • 1 year
|
0.31%
1/321 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place