| CTRI Number |
CTRI/2026/03/105887 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment Of Biliary Anatomy In Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
Comparative Evaluation Of Intravenous Versus Intracholecystic Indocyanine Green Injection For The Assessment Of Biliary Anatomy In Laparoscopic Cholecystectomy – A Randomized Control Study |
| 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 Satendra Kumar |
| Designation |
Professor and Head |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of General Surgery
Room no. 16, Ground floor
GIMS Hospital Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9911433771 |
| Fax |
|
| Email |
satensurg.sk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Gupta |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Room no. 16, Ground floor
GIMS Hospital Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9549157542 |
| Fax |
|
| Email |
0610ankitgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Gupta |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Room no. 16, Ground floor
GIMS Hospital Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
9549157542 |
| Fax |
|
| Email |
0610ankitgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of Institute of Medical Sciences (GIMS) Kasna, Greater Noida Gautam Buddha Nagar Pin-201310 |
|
|
Primary Sponsor
|
| Name |
Government of Institute of Medical Sciences (GIMS) |
| Address |
Kasna, Greater Noida Gautam Buddha Nagar Pin-201310 |
| Type of Sponsor |
Government medical college |
|
|
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 Ankit Gupta |
Government Institute of Medical Sciences (GIMS) |
Department of Surgery
OPD 16, Ground floor, GIMS Hospital, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9549157542
0610ankitgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intracholecystic ICG Administration |
IC administration entails direct injection of a diluted ICG solution into the gallbladder via laparoscopic needle or catheter. |
| Intervention |
Intravenous ICG Administration |
IV administration involves systemic delivery of ICG, typically 30–90 minutes preoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective laparoscopic cholecystectomy due to gallbladder
disease (acute or chronic cholecystitis, cholelithiasis). |
|
| ExclusionCriteria |
| Details |
1. H/O any allergy to dye/iodine
2.Pregnant or breastfeeding women.
3.Prior history of biliary tract surgery or malignancy
4.History of significant liver disease (e.g., cirrhosis, active hepatitis).
6. Severe renal insufficiency or renal failure.
7. Laparoscopic cholecystectomy done for perforation of gall bladder
8. Any other comorbidity due to which dye is contraindicated |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Extrahepatic biliary tree visualization.
2.Incidence of hepatic fluorescence interference.
3.Time taken during surgery
4.Bile spillage
5.Complications during and after surgery (CBD injury, Vessel injury etc.)
|
Patients will be monitored from baseline to the time of discharge at day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
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 3 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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
|
Years="1"
Months="6"
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
|
(1) STUDY DESIGN
Randomized Control study
(2) STUDY SETTING
This study will be carried out in the General Surgery Department of a tertiary hospital, over a period of 18 months, following ethical approval from the Institutional Review Board.
(3) STUDY POPULATION
All patients undergoing laparoscopic cholecystectomy for acute or chronic gallstone disease. |