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

Phase 4

• Conditions: Acute Cholecystitis; Acute; Cholecystitis, Choledocholithiasis; Acute Cholecystitis With Obstruction
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT04624841
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-13
• Last Update Posted: 2020-12-16
• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG group	Indocyanine Green	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.

Primary Outcome Measures

Name	Time	Method
Percentage of surgeries in which Critical View of Safety was achieved	Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.	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.

Secondary Outcome Measures

Name	Time	Method
Time taken to identify Critical View of Safety	After securing working ports till Clipping of Cystic Duct or Artery.	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.
Surgeon's Satisfaction Survey	Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.	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.

Trial Locations

Locations (1)

Hamad General Hospital; 🇶🇦 Doha, Qatar