Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Cholelithiasis
• Interventions: Diagnostic Test: Fluorescence Cholangiography

• Registration Number: NCT04228835
• Lead Sponsor: University of Malaya

Brief Summary

Achievement of critical view of safety (CVS) is recommended to reduce risk of hilar injury in laparoscopic cholecystectomy. Indocyanine green (ICG) fluorescence cholangiography, a novel technique of real time biliary visualization, is postulated to assist dissection during laparoscopic cholecystectomy (LC). However, its use in providing a faster and safer LC has yet to be established. The main objective of this study is to evaluate whether the use of ICG enhanced fluorescence cholangiography will help in earlier identification critical view of safety during LC.

Detailed Description

Indocyanine green (ICG) is excreted exclusively in the biliary system and emits fluorescence light when viewed using near infrared imaging. This enables extrahepatic biliary tree anatomy to be delineated during laparoscopic cholecystectomy.

Indocyanine green fluorescence cholangiography also enables earlier detection of cystic duct and common bile duct during laparoscopic cholecystectomy. This is reported in two studies which showed that cystic duct can be identified 11 minutes and 8.6 minutes earlier and common bile duct 10 and 11 minutes earlier than white light imaging.

To date, there is no data published on the use of fluorescent cholangiography in reducing operative time of identification of critical view of safety during laparoscopic cholecystectomy, which is an integral part of the surgery. Theoretically achievement of critical view of safety maybe facilitated by fluorescent cholangiography as this technique facilitates identification of biliary structures.

The primary objective of this study is to evaluate whether an earlier identification of CVS can be obtained by using ICG fluorescence cholangiography as an adjunct to conventional laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. Secondary outcomes assessed are the presence of minor or major complications between this two groups.

Patients are randomly assigned into two arms; ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy (LC), using a computer-generated block randomization. Patients in the ICGFC- LC group received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. All the surgeries are performed using standard four ports technique. Near infrared light camera by Karl Storz Endoscopy is used intermittently during dissection for the ICGFC-LC group.

Time to identification of CVS is defined by time of gallbladder retraction to time of establishment of critical view of safety. Critical view of safety is achieved when all the three criteria set by Strasberg is met. Mean time to identification of CVS in the two groups of patients were then compared. All patients are followed up for one month to identify any post-operative complications.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Study First Submitted: 2019-11-27
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-12
• Last Update Submitted: 2020-01-12
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Symptomatic cholelithiasis for elective cholecystectomy
• American Society of Anaesthesiologist (ASA) classification of physical status I or II
• Normal kidney function
• Normal liver function

Exclusion Criteria

• Liver cirrhosis
• Hepatits B or C
• Allergies to iodine or seafood

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICGFC-LC	Fluorescence Cholangiography	ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC-LC) arm patients received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. Near infrared laparoscopic light camera was utilized intermittently during dissection of Calot's triangle until critical view of safety was achieved.

Primary Outcome Measures

Name	Time	Method
Time to identification of critical view of safety	Time of surgery	Compare time to identification of critical view of safety during laparoscopic cholecystectomy which is defined as time of gallbladder retraction until establishment of critical view of safety.

Secondary Outcome Measures

Name	Time	Method
Complications	up to 30 days post operative	Compare rate of complications of laparoscopic cholecystectomy such as bile duct injury, major haemorrhage, intraabdominal collections and surgical site infection

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia