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

NCT04228835 | Completed

• 1 other identifier: 1001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiasis

Keywords

Symptomatic and Complicated Cholelithiasis

Outcome Measures

Primary Outcomes (1)

• Time to identification of critical view of safety

  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.

  Time of surgery

Secondary Outcomes (1)

• Complications

  up to 30 days post operative

Study Arms (2)

ICGFC-LC

EXPERIMENTAL

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.

Diagnostic Test: Fluorescence Cholangiography

Conventional LC

NO INTERVENTION

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

Interventions

Fluorescence Cholangiography DIAGNOSTIC_TEST

Administration of ICG for fluorescence cholangiography

ICGFC-LC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead
• Ummi Surgical Sdn Bhd: collaborator

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (3)

• Schols RM, Bouvy ND, van Dam RM, Masclee AA, Dejong CH, Stassen LP. Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013 Dec;27(12):4511-7. doi: 10.1007/s00464-013-3100-7. Epub 2013 Jul 23.

  PMID: 23877766 BACKGROUND

• van Dam DA, Ankersmit M, van de Ven P, van Rijswijk AS, Tuynman JB, Meijerink WJ. Comparing Near-Infrared Imaging with Indocyanine Green to Conventional Imaging During Laparoscopic Cholecystectomy: A Prospective Crossover Study. J Laparoendosc Adv Surg Tech A. 2015 Jun;25(6):486-92. doi: 10.1089/lap.2014.0248. Epub 2015 May 14.

  PMID: 25974072 BACKGROUND

• Koong JK, Ng GH, Ramayah K, Koh PS, Yoong BK. Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study. Asian J Surg. 2021 Mar;44(3):537-543. doi: 10.1016/j.asjsur.2020.11.002. Epub 2020 Nov 19.

  PMID: 33223453 DERIVED

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Jun Kit Koong, MS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer and Consultant Surgeon

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

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: January 14, 2020
• Study Start: March 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)