Brief Title
Visualization of the Extrahepatic biliaRy Tree Trial
Official Title
Evaluate the Efficacy of ICG Fluorescent Cholangiography for Visualization of Extrahepatic Biliary Anatomy in Emergency Cholecystectomy: A Single-Center, Randomized, Controlled, Parallel-Group Study
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.
Detailed Description
Near-infrared fluorescent imaging techniques have shown promise in aiding to delineate and
visualize extrahepatic biliary structures. Indocyanine green (ICG) is a water-soluble
fluorescent dye that has been shown to improve visualization of biliary anatomy under
fluorescent cholangiography. The standard of care for many acute biliary disease conditions,
such as acute cholecystitis, remains early laparoscopic cholecystectomy. Even though
real-time fluorescent cholangiography using ICG has the potential to enhance the
visualization of biliary structures and anatomy, and therefore reduce the risk for bile duct
injury, the majority of the studies published to date exclude acute biliary disease patients.
The pathophysiology of acute biliary disease processes is associated with inflammation and
adhesions that increase the challenge of achieving a critical view of safety. The
investigators propose that using ICG and fluorescent cholangiography near-infrared imaging
techniques as an adjunct in acute care laparoscopic cholecystectomies has the potential to
help mitigate the increased risk of bile duct injury by increasing extrahepatic biliary
structure detection and surgeon confidence.
Eligible patients will be identified through their initial clinical evaluation, which will be
verified by the patient's primary surgeon. If and once a patient has been confirmed as
eligible, the surgeon or designate will introduce the clinical trial design in detail. If
after being introduced to the study and having had the opportunity to ask questions, the
patient is willing to participate, the patient will be asked to review and sign the informed
consent document.
Upon entry into the clinical trial, the allocation sequence will be generated using a block
randomization schema with computer-generated random numbers in a 1:1 ratio, with block sizes
of 4 by a co-investigator with no clinical involvement in the trial. The same co-investigator
will prepare sequentially numbered, opaque, sealed and stapled envelopes and stored them in a
locked cabinet in the operating room control desk. Each envelope contained instructions for
the arm the participant had been randomly assigned to, either treatment (ICG cholangiography)
or control (standard white light only) arms. After the research team member has obtained the
participant's consent, the surgeon or designates will obtain the next consecutively numbered
envelope and proceed to open it after the patient is anesthetized and prior to beginning the
surgery.
The patient will be blinded to the result of the randomization until after surgery as the
envelope will be opened only after the patient has received their general anesthetic. No
blinding of the surgical team, research team members or outcomes assessors will be used in
this study given the procedural nature and acute condition of the patients included.
Study Type
Interventional
Primary Outcome
Detection rate of extrahepatic biliary structures
Secondary Outcome
Operative success
Condition
Cholecystitis, Acute
Intervention
Laparoscopic Cholecystectomy with Fluorescent Cholangiography
Study Arms / Comparison Groups
Near-Infrared Fluorescence Cholangiography
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
340
Start Date
August 2021
Completion Date
January 2023
Primary Completion Date
December 2022
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jean Philip Dawe, CD MD FRCSC, 6048755094, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04922528
Organization ID
H21-01375
Responsible Party
Principal Investigator
Study Sponsor
University of British Columbia
Study Sponsor
Jean Philip Dawe, CD MD FRCSC, Principal Investigator, Clinical Assistant Professor
Verification Date
June 2021