NCT04228835

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

Completed NA Last updated 14 January 2020

What this trial tests

NA trial testing Fluorescence Cholangiography in Cholelithiasis in 72 participants. Completed in 31 July 2019.

Timeline

1 March 2017

Primary endpoint
31 July 2019

31 July 2019

Quick facts

Lead sponsor	University of Malaya
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	72
Start date	1 March 2017
Primary completion	31 July 2019
Estimated completion	31 July 2019
Sites	1 location across Malaysia

Drugs / interventions tested

• Fluorescence Cholangiography

Conditions studied

• Cholelithiasis — all drugs for Cholelithiasis →

Sponsor

University of Malaya

Who can join

18 and older, any sex, with Cholelithiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application.
   Pesce A, Piccolo G, Lecchi F, Fabbri N, et al · · 2021 · cited 29× · PMID 34629815 · DOI 10.3748/wjg.v27.i36.5989
2. Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study.
   Koong JK, Ng GH, Ramayah K, Koh PS, et al · · 2021 · cited 20× · PMID 33223453 · DOI 10.1016/j.asjsur.2020.11.002