MedTrace Logo

Visualization of the Extrahepatic biliaRy Tree Trial

NCT04922528 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2021-06-15

No results posted yet for this study

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

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jean Philip Dawe, CD MD FRCSC · Clinical Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922528 on ClinicalTrials.gov