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CTRI Number  CTRI/2025/02/079963 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Studying the optimal dosage and timing of intervention (Indocyanin Green administration) in participants undergoing Laparoscopic Cholecystectomy.  
Scientific Title of Study   Optimization of Indocyanin Green (ICG) Administration for Enhanced Visualization of Extrahepatic Biliary System during Laparoscopic Cholecystectomy - A Pilot Randomized Control 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  Krishna Kalyan Reddy Janumpalli 
Designation  DrNB Resident - Surgical Gastroenterology 
Affiliation  National Institute of Gastroenterology and Liver Diseases 
Address  Ground floor, NIGL Hospital, Road No 12, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  8105135208  
Fax    
Email  kalyanreddy@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  R.V. Raghavendra Rao 
Designation  Surgical Gastroenterologist and Liver Transplant Surgeon 
Affiliation  National Institute of Gastroenterology and Liver Diseases 
Address  NIGL Hospital, Plot No 344A, MLA Colony, Road No 12, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  7993089995  
Fax    
Email  dnb.bh@renovahospitals.com  
 
Details of Contact Person
Public Query
 
Name  Krishna Kalyan Reddy Janumpalli 
Designation  DrNB Resident - Surgical Gastroenterology 
Affiliation  National Institute of Gastroenterology and Liver Diseases 
Address  Groud Floor, NIGL Hospital, Road No 12, Banjara Hills, Hyderabad


TELANGANA
500034
India 
Phone  8105135208  
Fax    
Email  kalyanreddy@outlook.com  
 
Source of Monetary or Material Support  
National Institute of Gastroenterology and Liver Diseases, Road No.12, Banjara Hills, Hyderabad -500034, Telangana, India 
 
Primary Sponsor  
Name  Department of Surgical Gastroenterology 
Address  National Institute of Gastroenterology and Liver Diseases, Road No. 12, Banjara Hills, Hyderabad-500034, Telangana, India 
Type of Sponsor  Private hospital/clinic 
 
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 
Krishna Kalyan Reddy Janumpalli  Department of Surgical Gastroenterology, National Institute of Gastroenterology and Liver Diseases  Ground Floor, Department of Surgical Gastroenterology
Hyderabad
TELANGANA 
8105135208

kalyanreddy@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee-Prime Hospital  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: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis, (4) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (5) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (6) ICD-10 Condition: K851||Biliary acute pancreatitis, (7) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Administration of 10 mg Indocyanin Green (ICG) at 4-6 hrs before surgery   10 mg of Indocyanin Green (ICG) is injected at the specified time before surgery  
Intervention  Administration of 2.5 mg Indocyanin Green (ICG) at 1hr before surgery  2.5 mg of Indocyanin Green (ICG) is injected at the specified time before surgery 
Comparator Agent  Administration of 25 mg Indocyanin Green (ICG) at 10-12 hrs before surgery   25 mg of Indocyanin Green (ICG) is injected at the specified time before surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients undergoing Laparoscopic Cholecystectomy will be given a choice to participate in the study 
 
ExclusionCriteria 
Details  Age more than 80 years
Age less than 18 years
Patients with Acute Cholecystitis
Patients with Iodine Allergy
Patients with allergy to test dose of Indocyanin Green (ICG)
Patients with Chronic Liver Disease
Patients on Chemotherapy
Patients with Hyperthyroid
Patients with Obesity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare effectiveness of preoperative ICG administration at 1 hr, 4-6hrs and 10-12 hrs prior to surgery to enhance intraoperative visualization of etrahepatic bile ducts  Outcome will be assessed intraoperatively during surgical procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
Visulaisation quality in 1 hr group, 4-6 hrs group & 10-12 hrs group  Outcome will be assessed intraoperatively during surgical procedure. 
Identification of critical structures in the groups  Outcome will be assessed intraoperatively during surgical procedure. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 4 
Date of First Enrollment (India)   15/02/2025 
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="10"
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  

Laparoscopic cholecystectomy is a minimally invasive surgical procedure used to remove the gallbladder, typically due to gallstones or other gallbladder diseases. However, one potential complication of the procedure is bile duct injury (BDI), which occurs when the bile duct is accidentally cut, clipped, or otherwise damaged during the procedure. Reported incidence of BDI varies between 0.2% to 0.7% but it can lead to serious complications such as bile leakage, infection, biliary peritonitis and even long-term health problems if not promptly identified and treated in addition to increased hospital stay and need for further interventions. Intraoperative cholangiography has been a traditional method used to visualize the bile duct anatomy during cholecystectomy but it involves injecting contrast dye into the bile duct and taking X-ray images to identify any abnormalities or injuries. It requires special expertise in technique and its interpretation, additional equipment, radiation exposure, and prolongs the surgical procedure. 


An emerging alternative to Intraoperative cholangiography is the use of indocyanine green (ICG) fluorescence imaging. ICG is a fluorescent dye that can be injected intravenously and visualized using specialized imaging systems during surgery. By selectively highlighting the bile duct and surrounding structures, ICG fluorescence imaging allows surgeons to better identify and avoid injuring the bile duct during LC. 

However, the timing of ICG administration plays a crucial role in adequate fluorescence of the extra hepatic bile ducts. The reason for this being background fluorescence from liver distorting the perception of bile ducts. If fluorescence imaging is performed immediately after the administration of ICG, the liver will be highly fluorescent while bile ducts will not yet contain enough ICG. On the other hand, if fluorescence imaging is performed too long after the administration of ICG, the fluorescence intensity of the common bile duct (CBD) and liver will be so low that it wouldn’t be conducive to identifying anatomical structures.

Hence in this context, the study being conducted to assess the optimal timing of ICG administration before Laparoscopic Cholecystectomy to enhance the visualization of extra hepatic bile ducts during surgery.


 
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