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

Hamad Medical Corporation (HMC)

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Industry

Identifiers

NCT04624841

U1111-1256-1361 (Other Identifier)

IRGC-05-NI-18-362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

ICG group

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine Green

No ICG Group

No Intervention group

Description:

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.