Visualization of the Extrahepatic biliaRy Tree Trial

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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