Visualization of the Extrahepatic biliaRy Tree Trial

NCT04922528 | Unknown

• 1 other identifier: H21-01375
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystitis, Acute; Acute Cholangitis; Gallstone Pancreatitis; Choledocholithiasis; Cholecystolithiasis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Disease; Calculi; Pathological Conditions, Anatomical

Keywords

Cholangiography; Indocyanine green; ICG; Fluorescent cholangiography; Biliary Anatomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operative success

  Intraoperatively

• Rates of conversion

  Intraoperatively

• Operative time

  Intraoperatively

• Surgeon satisfaction

  Through participant discharge, an average of 1 week

Other Outcomes (2)

• Adverse events

  Through participant discharge, an average of 1 week

• Procedural complications

  Through participant discharge, an average of 1 week

Study Arms (2)

Near-Infrared Fluorescence Cholangiography

EXPERIMENTAL

Standard laparoscopic cholecystectomy completed with a combination of white light imaging and near-Infrared fluorescence cholangiography after administering 5 mg of a 25 mg/10 mL solution of indocyanine green (ICG) intravenously prior to the operation

Procedure: Laparoscopic Cholecystectomy with Fluorescent Cholangiography; Procedure: Laparoscopic Cholecystectomy with White Light Imaging

White Light Imaging

ACTIVE COMPARATOR

Standard laparoscopic cholecystectomy completed with only standard white light imaging only

Procedure: Laparoscopic Cholecystectomy with White Light Imaging

Interventions

Laparoscopic Cholecystectomy with Fluorescent Cholangiography PROCEDURE

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.

Near-Infrared Fluorescence Cholangiography

Laparoscopic Cholecystectomy with White Light Imaging PROCEDURE

As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.

Near-Infrared Fluorescence Cholangiography; White Light Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission or consultation by the Acute Care Surgery (ACS) service
• Diagnosis of acute biliary disease requiring index laparoscopic cholecystectomy
• Diagnoses of acute cholangitis, choledocholithiasis, and gall stone pancreatitis may be included. However, they must have cleared ducts confirmed via endoscopic ultrasound, ultrasound, ERCP, and/or laboratory investigations.
• Ability to understand and follow study procedures and protocols, and provide signed informed consent.

You may not qualify if:

• Female patients who are pregnant or currently breastfeeding
• Known pre-existing liver disease, including cirrhosis
• Known allergy to iodine or shellfish
• Known allergy to indocyanine green (ICG)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (2)

• 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.

  PMID: 27151917 BACKGROUND

• 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.

  PMID: 31744398 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute; Choledocholithiasis; Cholecystolithiasis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Calculi; Pathological Conditions, Anatomical

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Cholecystitis; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Jean Philip Dawe, CD MD FRCSC

  Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karan J D'Souza, MD MPH MM

CONTACT

6048755094; karan.dsouza@alumni.ubc.ca

Jean Philip Dawe, CD MD FRCSC

CONTACT

6048755094; philip.dawe@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the procedural nature of the intervention, we have chosen to run this trial single-blinding, with only the participant being masked to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The intervention and comparator arms will be ran in parallel, with a block randomization sequence determining the participants allocations.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 10, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)