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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.
 
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