| CTRI Number |
CTRI/2024/11/076948 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Study to evaluate benefit of ICG dye on operative
efficacy in patients undergoing difficult
laparoscopic cholecystectomy. |
Scientific Title of Study
Modification(s)
|
A randomized trial to visualize extrahepatic
biliary structures with or without indocyanine
green in patients undergoing difficult laparoscopic
cholecystectomy.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Virinder Kumar Bansal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 405, 4th Floor, Dept. Of Surgical Disciplines, AIIMS Campus, Masjid Moth, South Extension 2, New Delhi - 110029
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yashwant Singh Rathore |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 429, 4th Floor, Dept. Of Surgical Disciplines, AIIMS Campus, Masjid Moth, South Extension 2, New Delhi - 110029
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9911337726 |
| Fax |
|
| Email |
dryashvant.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U Rohit |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Surgery Office, Room 421, 4th Floor, Department of Surgical Disciplines, Surgery Block, AIIMS Campus, Masjid Moth, New Delhi - 110029
South
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9679536380 |
| Fax |
|
| Email |
urohitsonu@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi - 110029 South delhi
DELHI
INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences , New Delhi |
| Address |
Ansari Nagar, New Delhi-110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Virinder Kumar Bansal |
All India Institute Of Medical Sciences, New delhi |
Room No.: 410 ,Second Floor, Department Of Surgical Disciplines, Surgery Block, All India Institute Of Medical Sciences ,Ansari Nagar, New Delhi-110029
South
DELHI |
9810348479
drvkbansal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K80||Cholelithiasis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
ICG (Indocyanine green ) GROUP |
Indocyanine green (ICG) dye will be reconstituted
with 5 ml of sterile water and shaken well for
atleast for 3 minutes. Dose of 10 mg (2ml) will be
given intravenously 10-12 hours prior to
laparoscopic Cholecystectomy . |
| Comparator Agent |
Non ICG GROUP |
Conventional Laparoscopic Cholecystectomy will be done without ICG. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Surgical Cholecystectomy Score (SCS) 2 or more |
|
| ExclusionCriteria |
| Details |
1.Age < 18 yrs or > 70 yrs
2.Prior history of hepato-biliary surgery
3.Allergy to ICG dye
4.Hepatobiliary malignancy
5.Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To evaluate the effectiveness of ICG in
visualization of extrahepatic biliary structures
during difficult laparoscopic cholecystectomy by
visual analogue score (VAS) and mean green
colour intensity (GCI). |
At time of surgery
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.To compare the rate of bile duct injury in both
groups
2.Conversion to open
3.Operating Time
4.To measure the length of hospital stay
5.To evaluate postoperative complications – bile
leak & SSI |
At time of surgery
1 week
4 weeks
6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="208"
Sample Size from India="208"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy (LC) is the gold
standard for the treatment of symptomatic gall stone disease which is a major
health problem affecting 1.39 per 100 person-years. Surgeons often encounter a ―Difficult Gall
bladder during which achieving Critical view of safety is difficult and unsafe. Additionally, anatomical variations, such as a
short cystic duct or low-lying gallbladder , complicate the procedure and
heighten the risk of bile duct injury .Dense adhesions ,previous surgeries or inflammation can obscure the
surgical field, making the identification and dissection of the cystic duct and
artery difficult. Fluorescent cholangiography using ICG will enable real-time identification of the
cystic duct , common hepatic duct and common bile duct ,as well as accessory hepatic ducts during the dissection of the triangle
of Calot. This safe and simple technique is helpful in improve safety in difficult cases of laparoscopic cholecystectomy and thereafter avoiding bile duct injury.In this study, we wish to evaluate the impact of ICG in improving operative efficacy and safety during difficult laparoscopic cholecystectomy, along with long term outcomes and Quality of life. |