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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04922528
Other study ID # H21-01375
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2021
Est. completion date January 2023

Study information

Verified date June 2021
Source University of British Columbia
Contact Karan J D'Souza, MD MPH MM
Phone 6048755094
Email karan.dsouza@alumni.ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Participants will be randomized into either the control arm, which uses the standard of care white light during laparoscopy or the intervention arm, which will use ICG fluorescent cholangiography as an adjunct to white light to visualize the biliary anatomy. The investigators hypothesize that the use of fluorescent cholangiography will increase the rates of identification of important biliary anatomy during laparoscopic cholecystectomy. The effectiveness, feasibility, and safety will be compared between the two groups using a post-operative survey form the surgeons will complete prior to exiting the operating room.


Description:

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Study Design


Intervention

Procedure:
Laparoscopic Cholecystectomy with Fluorescent Cholangiography
Indocyanine green is a fluorophore molecule which is metabolized by the liver and excreted exclusively through the biliary system. Intra-operatively, near-infared imaging via the laparoscope will be used to visualize the biliary anatomy in the intervention arm, as an adjunct to standard of care white-light imaging.
Laparoscopic Cholecystectomy with White Light Imaging
As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Bleszynski MS, DeGirolamo KM, Meneghetti AT, Chiu CJ, Panton ON. Fluorescent Cholangiography in Laparoscopic Cholecystectomy: An Updated Canadian Experience. Surg Innov. 2020 Feb;27(1):38-43. doi: 10.1177/1553350619885792. Epub 2019 Nov 19. — View Citation

Zroback C, Chow G, Meneghetti A, Warnock G, Meloche M, Chiu CJ, Panton ON. Fluorescent cholangiography in laparoscopic cholecystectomy: the initial Canadian experience. Am J Surg. 2016 May;211(5):933-7. doi: 10.1016/j.amjsurg.2016.01.013. Epub 2016 Feb 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events Any adverse events associated with the administration or use of ICG fluorescent cholangiography Through participant discharge, an average of 1 week
Other Procedural complications Any complications associated with the cholecystectomy Through participant discharge, an average of 1 week
Primary Detection rate of extrahepatic biliary structures The extrahepatic biliary structures which we will be assessing the identification of include: Cystic Duct (CD), Right Hepatic Duct (RHD), Common Hepatic Duct (CHD), Common Bile Duct (CBD), Cystic Duct - Gall Bladder junction (CD-GB), and Cystic Duct - Common Bile Duct junction (CD-CBD). Intraoperatively
Secondary Operative success Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement. Intraoperatively
Secondary Rates of conversion Rate of conversion to open cholecystectomy. Intraoperatively
Secondary Operative time From the time of opening the skin to the time of closure. Intraoperatively
Secondary Surgeon satisfaction Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality. Through participant discharge, an average of 1 week
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