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CTRI Number  CTRI/2024/10/075575 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The adjuvant use of indocyanine green dye to facilitate the visibility of extrahepatic biliary ducts, to prevent injury during difficult cholecystectomy:A randomised trial 
Scientific Title of Study   Impact of Indocyanine Green Fluorescence on Surgical Precision in Difficult Cholecystectomy - A Randomized 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  Dr Anita Dhar 
Designation  professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Room no 430 Department of Surgical Disciplines AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  09810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Dhar 
Designation  professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Room no 430 Department of Surgical Disciplines AIIMS New Delhi

South
DELHI
110029
India 
Phone  09810198239  
Fax    
Email  dranitadharbhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishnukant Pandey 
Designation  Senior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES 
Address  Room no 430 Department of Surgical Disciplines AIIMS New Delhi

South
DELHI
110029
India 
Phone  8989963540  
Fax    
Email  drvkant@gmail.com  
 
Source of Monetary or Material Support  
room no 430 Department of Surgical Disciplines AIIMS New Delhi AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  room no. 430, Department of Surgical Disciplines,AIIMS New Delhi  
Type of Sponsor  Research institution and hospital 
 
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 Anita Dhar  All India Institute of Medical Sciences New Delhi  Room no 430 Department of Surgical Disciplines AIIMS New Delhi
South
DELHI 		 09810198239

dranitadharbhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control  no icg will be used 
Intervention  Indocyanine Green  dose 0.2 mg/kg body weight of indocyanine Green will be given intravenously night 10 hours before surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Age ≥ 18 years
2 Gall stone disease patients with moderate and high risk of difficult cholecystectomy on preoperative risk assessment scale
3 Hemodynamically stable
4 Fit for General anaesthesia
• Laparoscopic cholecystectomy indicated either interval or immediate( within 72 hrs of presentation).
 
 
ExclusionCriteria 
Details  1 Allergy to Indocyanine green (ICG)
2 Patients with low risk of difficult cholecystectomy on preoperative risk assessment scale
3 Patient for which consent could not be obtained.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Operative time from insertion of ports to achieving critical view of safety (CVS).  once on operation table 
 
Secondary Outcome  
Outcome  TimePoints 
blood loss  once on operation table 
Bile duct injury  once on operation table 
Conversion to open  once on operation table 
Post operative bile leak  once on operation table 
Hospital stay  once on operation table 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   31/10/2024 
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   Surgical anatomy is difficult to visualised frequently in difficult cholecystectomies , therefore number of patients with CBD injury is higher than regular cholecystectomies hence there is a need to support the process of identification of anatomy to visualise the critical view of safety. Additionally intraoperative fluorescence imaging with ICG was recently shown to be an alternative to intraoperative cholangiography for visualizing the extrahepatic biliary structures during laparoscopic cholecystectomy ( LC).Surgical anatomy is difficult to visualised frequently in difficult cholecystectomies , therefore number of patients with CBD injury is higher than regular cholecystectomies hence there is a need to support the process of identification of anatomy to visualise the critical view of safety. Additionally intraoperative fluorescence imaging with ICG was recently shown to be an alternative to intraoperative cholangiography for visualizing the extrahepatic biliary structures during laparoscopic cholecystectomy ( LC). 
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