Trial Outcomes & Findings for Low Dose ICG for Biliary Tract and Tumor Imaging (NCT NCT04942665)
NCT ID: NCT04942665
Last Updated: 2023-08-30
Results Overview
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
intraoperative, average of 2 hours
Results posted on
2023-08-30
Participant Flow
Patients undergoing a planned laparoscopic cholecystectomy were approached between September 2021 to August 2022 in pre-surgical clinic and consented for a randomized ICG dose administration.
No enrolled patients were excluded from the study prior to group assignment.
Participant milestones
| Measure |
Low Dose
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
PINPOINT Endoscopic Fluorescence: The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.
|
Standard Dose
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
COMPLETED
|
32
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Dose ICG for Biliary Tract and Tumor Imaging
Baseline characteristics by cohort
| Measure |
Low Dose
n=32 Participants
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
Standard Dose
n=28 Participants
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Continuous
|
53 years
n=99 Participants
|
60 years
n=107 Participants
|
57 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
26 participants
n=99 Participants
|
24 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
28 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intraoperative, average of 2 hoursMeasurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver
Outcome measures
| Measure |
Low Dose
n=29 Participants
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
Standard Dose
n=26 Participants
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
|---|---|---|
|
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
|
2.7 ratio
Interval 1.5 to 4.2
|
0.7 ratio
Interval 0.6 to 0.8
|
SECONDARY outcome
Timeframe: intraoperative, average of 2 hoursA qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).
Outcome measures
| Measure |
Low Dose
n=29 Participants
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
Standard Dose
n=26 Participants
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
|---|---|---|
|
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light
|
3.4 score on a scale
Standard Deviation 1.3
|
3.1 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: intraoperative, average of 2 hoursMeasurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat
Outcome measures
| Measure |
Low Dose
n=29 Participants
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
Standard Dose
n=26 Participants
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
|---|---|---|
|
Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio
|
6.1 ratio
Interval 4.9 to 10.5
|
2.7 ratio
Interval 2.4 to 3.0
|
SECONDARY outcome
Timeframe: intraoperative, average of 2 hoursA qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).
Outcome measures
| Measure |
Low Dose
n=29 Participants
Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
Standard Dose
n=26 Participants
Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.
Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
|
|---|---|---|
|
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
Common Hepatic Duct
|
3.6 score on a scale
Standard Deviation 1.4
|
2.8 score on a scale
Standard Deviation 1.3
|
|
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
Cystic Duct
|
3.6 score on a scale
Standard Deviation 1.3
|
3.5 score on a scale
Standard Deviation 1.2
|
|
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
Common Bile Duct
|
3.6 score on a scale
Standard Deviation 1.3
|
3.1 score on a scale
Standard Deviation 1.3
|
|
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
Aberrant Duct
|
2.8 score on a scale
Standard Deviation 1.3
|
2.3 score on a scale
Standard Deviation 0.4
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place