Trial Outcomes & Findings for Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease) (NCT NCT03245580)
NCT ID: NCT03245580
Last Updated: 2022-04-07
Results Overview
To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
At day 7 post biopsy
Results posted on
2022-04-07
Participant Flow
Participant milestones
| Measure |
Arm 1 -Modified Wet Suction
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
|
Overall Study
COMPLETED
|
75
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
Baseline characteristics by cohort
| Measure |
Arm 1 -Modified Wet Suction
n=75 Participants
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=78 Participants
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
n=5 Participants
|
56.6 years
n=7 Participants
|
55.85 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Hypertension
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Diabetic
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Anticoagulants/Antiplatelet Therapy
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 7 post biopsyTo determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
Outcome measures
| Measure |
Arm 1 -Modified Wet Suction
n=150 Total number liver biopsy specimens
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=154 Total number liver biopsy specimens
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Pathological Yield Fragmentation
Length of Longest Fragment- Left Lobe
|
14 mm
Interval 11.0 to 20.0
|
11 mm
Interval 6.0 to 15.0
|
|
Pathological Yield Fragmentation
Length of Longest Fragment- Right Lobe
|
13 mm
Interval 9.0 to 19.0
|
10 mm
Interval 8.0 to 15.0
|
PRIMARY outcome
Timeframe: At time of completion of pathology reportTo determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.
Outcome measures
| Measure |
Arm 1 -Modified Wet Suction
n=147 Number of liver biopsy specimens
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=151 Number of liver biopsy specimens
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Pathological Yield Length
Total Length of Fragments - Left Lobe
|
46.5 mm
Interval 31.0 to 71.0
|
34.5 mm
Interval 17.0 to 42.0
|
|
Pathological Yield Length
Total Length of Fragments-Right Lobe
|
38 mm
Interval 22.0 to 60.0
|
28 mm
Interval 17.0 to 40.0
|
PRIMARY outcome
Timeframe: At time of completion of pathology reportTo determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.
Outcome measures
| Measure |
Arm 1 -Modified Wet Suction
n=150 Number of liver biopsy specimens
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=154 Number of liver biopsy specimens
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Pathological Yield Quantity
Total Number of Portal Tracts Left Lobe
|
16 Number of portal tracts
Interval 12.0 to 24.5
|
11.5 Number of portal tracts
Interval 6.5 to 18.5
|
|
Pathological Yield Quantity
Total Number of Portal Tracts Right Lobe
|
14 Number of portal tracts
Interval 10.0 to 18.0
|
12 Number of portal tracts
Interval 7.0 to 17.0
|
SECONDARY outcome
Timeframe: Complications occurring at time of consent, at procedure time and at day 7 post procedureTracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.
Outcome measures
| Measure |
Arm 1 -Modified Wet Suction
n=75 Participants
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=78 Participants
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Complications
Minor Adverse Events Grade 1
|
10 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Complications
Minor Adverse Events Grade 2
|
1 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Complications
Minor Adverse Events Grade 3
|
2 Number of Adverse Events
|
2 Number of Adverse Events
|
|
Complications
Serious Adverse Events Grade 1
|
7 Number of Adverse Events
|
2 Number of Adverse Events
|
Adverse Events
Arm 1 -Modified Wet Suction
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 2- Slow Pull
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 -Modified Wet Suction
n=75 participants at risk
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=78 participants at risk
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
3/75 • Number of events 3 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Psychiatric disorders
Agitation
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Vascular disorders
Hematoma
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Gastrointestinal disorders
Intraabdominal Hemorrhage
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
Other adverse events
| Measure |
Arm 1 -Modified Wet Suction
n=75 participants at risk
Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
Arm 2- Slow Pull
n=78 participants at risk
Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.0%
6/75 • Number of events 6 • Data collected for one week following procedure
|
2.6%
2/78 • Number of events 2 • Data collected for one week following procedure
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • Data collected for one week following procedure
|
2.6%
2/78 • Number of events 2 • Data collected for one week following procedure
|
|
Infections and infestations
Fever
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Nervous system disorders
Presyncope
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Nervous system disorders
Flank Pain
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/75 • Data collected for one week following procedure
|
1.3%
1/78 • Number of events 1 • Data collected for one week following procedure
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
|
Infections and infestations
Bronchial Infection
|
1.3%
1/75 • Number of events 1 • Data collected for one week following procedure
|
0.00%
0/78 • Data collected for one week following procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place