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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

NCT01424215

Cholelithiasis Cholecystitis Pancreatitis Biliary +1 more

COMPLETED NA

Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

NCT06918210

Gallstone Gallstone; Cholecystitis, Acute

NOT_YET_RECRUITING NA

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

NCT04624841

Acute Cholecystitis Acute; Cholecystitis, Choledocholithiasis Acute Cholecystitis With Obstruction

UNKNOWN PHASE4

Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy

NCT05125653

Cholecystitis Chronic Calculous Cholecystitis Acute Calculous Cholecystitis

COMPLETED NA

Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy

NCT04908826

Laparoscopic; Cholecystectomy Cholelithiasis; Bile Duct Choledocholithiasis +6 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholelithiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are divided into two arms: ICG enhanced fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICGFC-LC

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.

Group Type EXPERIMENTAL

Fluorescence Cholangiography

Intervention Type DIAGNOSTIC_TEST

Administration of ICG for fluorescence cholangiography

Conventional LC

Conventional laparoscopic cholecystectomy (LC) arm patients underwent standard white light laparoscopic cholecystectomy without fluorescence cholangiography.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluorescence Cholangiography

Administration of ICG for fluorescence cholangiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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