Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis

Study Overview
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Brief Summary
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The purpose of this prospective randomized trial is to study the role of Indocyanine green (ICG) to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy for patients with Acute Cholecystitis.

Detailed Description
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After informing about the study and obtaining consent to participate, patients who are diagnosed with Acute Cholecystitis and posted for emergency Laparoscopic Cholecystectomy will be randomly assigned to receive either ICG or not as a method to identify the Critical View of Safety during the operation. The primary outcome is whether there was a precise and satisfactory visualization of the junction between the cystic duct, the common hepatic duct, and the common bile duct by indocyanine green compared to the control group. The time taken to achieve this will be measured in minutes from video recordings of the laparoscopic surgery. The process will be further assessed by a surgeons' satisfaction score. The expected duration of the study will be 12 months involving a total of 80 patients randomized into two groups- 40 patients in the intervention group and 40 patients in the control group. The expected outcome of the study is that ICG is more effective than the control group in providing precise and satisfactory visualization of Critical View of Safety and takes less time. We predict the surgeons to be equally or more satisfied with ICG compared to control.

Official Title
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Role of Indocyanine Green in Visualizing Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis

Conditions
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Acute Cholecystitis, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for emergency Laparoscopic Cholecystectomy for Acute Cholecystitis Patient age ≥ 18 years. Patients who consent to take part in the study Exclusion Criteria: Preoperative planned for Open Cholecystectomy Allergy towards iodine, iohexol or ICG Pregnancy or lactation Renal insufficiency Legally incompetent for any reason Withdrawal of inclusion consent at any time Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG group<br>Participants receive an intravenous injection of 0.05 mg/kg of ICG 45 minutes preoperatively. A Pinpoint Endoscopic Fluorescence System (Novadac Technologies Inc., Canada) for ICG Fluorescence Observation with the easy switchable white light-fluorescent mode is used. Before dividing any tubular structure, the fluorescence imaging mode is routinely used again, and fluorescent angiography is performed by re-injecting the same dose of ICG as initially used. After the division of the cystic duct and artery, the fluorescence imaging mode is applied again to check for bile leakage. | Drug: Indocyanine Green<br>* 2.5-7.5 mg (0.05 mg/kg) injection<br>* Other names: fluorescent Imaging;|
| No Intervention: No ICG Group<br>No ICG is administered after randomization of the patient to a control group and hence will not produce any enhancement of the image on A Pinpoint Endoscopic Fluorescence System for ICG Fluorescence Observation. This will continue as a routine Laparoscopic cholecystectomy without fluorescent imaging enhancement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of surgeries in which Critical View of Safety was achieved | Percentage of surgeries where there was complete visualization of Critical View of Safety by intraoperative fluorescent cholangiography compared to the control group with no fluorescent imaging. Complete visualization of the Critical View of Safety is defined by the SAGS guidelines. The laparoscopic procedure is recorded & assessed individually & separately by two consultant surgeons who are not the operating surgeon whether the Critical View of Safety was achieved prior to clipping of Cystic Duct & Cystic Artery. Failure of identification of Critical View of Safety is defined as the need for further conventional intraoperative cholangiography or open conversion due to inability to accurately identify the biliary anatomy to complete the cholecystectomy safely. | Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to identify Critical View of Safety | Time taken by intraoperative fluorescent cholangiography or control group to identify Critical View of Safety. The laparoscopic procedure is recorded and Time taken is recorded by the Primary Investigator as the total time between successful introduction of the operative ports until the Critical View of Safety is achieved and Cystic Duct and Cystic Artery are clipped. | After securing working ports till Clipping of Cystic Duct or Artery. | 
| Surgeon's Satisfaction Survey | Surgeon satisfaction survey will be completed by the operating surgeon intraoperatively by answering the question Are you satisfied to proceed with the laparoscopic cholecystectomy without a conventional intraoperative cholangiography?. The answers will be a binary Yes or No. | Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute cholecystitis, laparoscopic cholecystectomy, critical view of safety, safe cholecystectomy, indocyanine green, operative cholangiogram, fluorescent imaging, near-infrared imaging