Visualization of the Extrahepatic biliaRy Tree Trial (VERT)
Primary Purpose
Cholecystitis, Acute, Acute Cholangitis, Gallstone Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Laparoscopic Cholecystectomy with Fluorescent Cholangiography
Laparoscopic Cholecystectomy with White Light Imaging
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis, Acute focused on measuring Cholangiography, Indocyanine green, ICG, Fluorescent cholangiography, Biliary Anatomy
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)
Sites / Locations
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Near-Infrared Fluorescence Cholangiography
White Light Imaging
Arm 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
Standard laparoscopic cholecystectomy completed with only standard white light imaging only
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Operative success
Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.
Rates of conversion
Rate of conversion to open cholecystectomy.
Operative time
From the time of opening the skin to the time of closure.
Surgeon satisfaction
Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.
Full Information
NCT ID
NCT04922528
First Posted
May 31, 2021
Last Updated
June 10, 2021
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04922528
Brief Title
Visualization of the Extrahepatic biliaRy Tree Trial
Acronym
VERT
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention and comparator arms will be ran in parallel, with a block randomization sequence determining the participants allocations.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Near-Infrared Fluorescence Cholangiography
Arm Type
Experimental
Arm 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
Arm Title
White Light Imaging
Arm Type
Active Comparator
Arm Description
Standard laparoscopic cholecystectomy completed with only standard white light imaging only
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy with Fluorescent Cholangiography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Cholecystectomy with White Light Imaging
Intervention Description
As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.
Primary Outcome Measure Information:
Title
Detection rate of extrahepatic biliary structures
Description
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).
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Operative success
Description
Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.
Time Frame
Intraoperatively
Title
Rates of conversion
Description
Rate of conversion to open cholecystectomy.
Time Frame
Intraoperatively
Title
Operative time
Description
From the time of opening the skin to the time of closure.
Time Frame
Intraoperatively
Title
Surgeon satisfaction
Description
Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.
Time Frame
Through participant discharge, an average of 1 week
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Any adverse events associated with the administration or use of ICG fluorescent cholangiography
Time Frame
Through participant discharge, an average of 1 week
Title
Procedural complications
Description
Any complications associated with the cholecystectomy
Time Frame
Through participant discharge, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karan J D'Souza, MD MPH MM
Phone
6048755094
Email
karan.dsouza@alumni.ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Philip Dawe, CD MD FRCSC
Phone
6048755094
Email
philip.dawe@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Philip Dawe, CD MD FRCSC
Organizational Affiliation
Clinical Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Philip Dawe, CD MD FRCSC
Phone
6048755094
Email
philip.dawe@vch.ca
First Name & Middle Initial & Last Name & Degree
Karan J D'Souza, MD MPH MM
Phone
6048755094
Email
karan.dsouza@alumni.ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27151917
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.
Results Reference
background
PubMed Identifier
31744398
Citation
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.
Results Reference
background
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Visualization of the Extrahepatic biliaRy Tree Trial
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