| CTRI Number |
CTRI/2025/12/099707 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Bile Duct Safety in Gallbladder Surgery With and Without Indocyanin Green Fluorescent Dye (ICG) |
|
Scientific Title of Study
|
Comparing the Incidence of Bile Duct Injuries in
Laparoscopic Cholecystectomy with and without use of Indocyanin green fluorescence dye (ICG) - A Randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aiswaryaa B |
| Designation |
Postgraduate in General Surgery |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
C block,Department of General Surgery,Aarupadai Veedu Medical College,Kirumampakkam ,Puducherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
8754888268 |
| Fax |
|
| Email |
aiswaryaabalamurugan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akmal A |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room No 10, C Block,Department of General Surgery, Aarupadai Veedu Medical College , Kirumampakkam
Puducherry
,Puducherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
8939932440 |
| Fax |
|
| Email |
aakmal04@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aiswaryaa B |
| Designation |
Postgraduate in General Surgery |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
C block,Department of General Surgery,Aarupadai Veedu Medical College,Kirumampakkam ,Puducherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
8754888268 |
| Fax |
|
| Email |
aiswaryaabalamurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College,Kirumampakkam,Pondicherry,607402,
India |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College |
| Address |
C block, Department of General Surgery,Kirumampakkam,Puducherry
607402 . |
| Type of Sponsor |
Private 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 Aiswaryaa B |
Aarupadai Veedu Medical College |
C block,Department Of General Surgery,Aarupadai Veedu Medical College,Kirumampakkam,Puducherry. Pondicherry PONDICHERRY |
8754888268
aiswaryaabalamurugan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K810||Acute cholecystitis, (3) ICD-10 Condition: K811||Chronic cholecystitis, (4) ICD-10 Condition: K824||Cholesterolosis of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Laparoscopic Cholecystectomy |
Standard laparoscopic cholecystectomy performed without the use of Indocyanine Green fluorescence dye. Conventional white light imaging will be used during dissection.
Duration of intervention: Single operative procedure. |
| Intervention |
Indocyaninin Green Fluorescence Dye Guidance |
Laparoscopic cholecystectomy performed with the use of Indocyanine Green (ICG) fluorescence dye for biliary anatomy visualization. ICG will be administered intravenously at the dose of 0.25 mg/kg approximately 45 to 60 minutes prior to surgery. Near-infrared fluorescence imaging will be utilized during the dissection of Calot’s triangle.
Duration of the intervention: Single-dose intravenous administration prior to surgery (45 to 60 minutes) with intraoperative fluorescence guidance during a single operative procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 years to 60 years undergoing elective and emergency laparoscopic cholecystectomy.
2.Patients diagnosed with Acute cholecystitis, chronic cholelithiasis, gall bladder empyema or gallbladder polyps.
3.ASA Physical Status I–III.
|
|
| ExclusionCriteria |
| Details |
1.Suspected or confirmed malignancy of the gallbladder or biliary tract.
2.Known anatomic biliary tract anomalies (e.g. choledochal cysts,biliary atresia).
3.Patients with severe liver dysfunction (e.g. Child-Pugh Class B or C).
4.Pregnant or breastfeeding women.
5.Patients with renal failure (as ICG clearance may be altered)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the incidence of bile duct injury between ICG fluorescence–guided laparoscopic cholecystectomy and Standard laparoscopic cholecystectomy without ICG fluorescence. |
From intraoperative period up to postoperative hospital stay,1 month and 3 month follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of successful identification of the critical view of safety during dissection |
Intraoperative period |
| Operative time measured from skin incision to port closure in minutes |
Intraoperative period |
Intraoperative complications including
bleeding
bile duct injury
gallbladder perforation
conversion to open surgery
|
Intraoperative period |
Postoperative complications like
fever
wound infection
bile leak
jaundice |
Postoperative
hospital stay
one month
three months follow up |
Duration of hospital stay
(number of days from surgery to discharge) |
Postoperative period until discharge |
| Need for re-intervention |
Postoperative
hospital stay
one month
three months follow up |
Time taken for identification of key anatomical structures like
cystic duct
cystic artery
common bile duct |
Intraoperative period |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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) |
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
|
After obtaining approval from the Institutional Research Committee and Institutional Humuan Ethics Committee, patients planned for laparoscopic cholecystectomy who fulfill the inclusion and exclusion criteria will be enrolled in the study after taking written informed consent. The nature, purpose, benefits and possible risks of the study will be explained to all participants. Participation will be voluntary and patients may withdraw at any time without affecting their treatment.
A total of 60 patients with symptomatic gallstone disease will be included and randomly allocated into two groups using group allocation concealment method. In Group A, laparoscopic cholecystectomy will be performed with the use of Indocyanine Green fluorescence dye for enhanced visualization of biliary anatomy. In Group B, standard laparoscopic cholecystectomy will be performed without the use of Indocyanine Green fluorescence guidance. The operating surgeon will assess the biliary anatomy and proceed as per standard surgical protocol.
The primary objective of the study is to compare the incidence of bile duct injuries between the two groups. Secondary outcomes include clear identification of the critical view of safety, operative time, conversion to open cholecystectomy, intraoperative and postoperative complications, length of postoperative hospital stay and the need for any re-intervention. Postoperative follow-up will be done at the time of discharge, at 1 month and at 3 months to assess recovery and detect any complications. The estimated duration of the study is 18 months. |