| CTRI Number |
CTRI/2026/02/102890 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of fluorescent dye to see bile ducts better during laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Role of Indocyanine Green (ICG) dye in delineation of biliary tract anatomy during 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 KHUSHBU GAUTAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Surgery, UPUMS, SAIFAI, ETAWAH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7060814211 |
| Fax |
|
| Email |
drkhushbug1708@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHUSHBU GAUTAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Surgery, UPUMS, SAIFAI, ETAWAH
UTTAR PRADESH
206130
India |
| Phone |
7060814211 |
| Fax |
|
| Email |
drkhushbug1708@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KHUSHBU GAUTAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Surgery, UPUMS, SAIFAI, ETAWAH
UTTAR PRADESH
206130
India |
| Phone |
7060814211 |
| Fax |
|
| Email |
drkhushbug1708@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI, ETAWAH |
| 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 Khushbu Gautam |
Uttar Pradesh University of Medical Sciences |
Department of Surgery, Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH |
7060814211
drkhushbug1708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green dye |
1 ml of ICG (0.2mg/kg) intravenously approximately 2 hours prior to laparoscopic procedure |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) All the patients diagnosed with cholelithiasis with acute/ chronic cholecystitis planned for laparoscopic cholecystectomy.
2) Patient more than 14 years of age |
|
| ExclusionCriteria |
| Details |
1) Patients allergic to iodine salts/ iodized dyes
2) Patients not giving consent for the procedure |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Role of ICG efficiency in effective delineation of biliary tract anatomy |
Role of ICG efficiency in effective delineation of biliary tract anatomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Role of ICG in avoiding bile duct injuries during laparoscopic cholecystectomy |
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This prospective, non-randomised, single-arm interventional study evaluates the role of indocyanine green (ICG) dye in delineating biliary tract anatomy during laparoscopic cholecystectomy. Sixty adult patients undergoing elective or emergency laparoscopic cholecystectomy will be included. ICG will be administered intravenously prior to surgery, and near-infrared fluorescence imaging will be used intraoperatively to visualise biliary anatomy and critical structures. Intraoperative findings and postoperative complications will be recorded. The study aims to assess the effectiveness of ICG in improving anatomical identification and reducing the risk of bile duct injury during laparoscopic cholecystectomy. |