- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922528
Visualization of the Extrahepatic biliaRy Tree Trial (VERT)
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 Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karan J D'Souza, MD MPH MM
- Phone Number: 6048755094
- Email: karan.dsouza@alumni.ubc.ca
Study Contact Backup
- Name: Jean Philip Dawe, CD MD FRCSC
- Phone Number: 6048755094
- Email: philip.dawe@vch.ca
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Contact:
- Karan J D'Souza, MD MPH MM
- Phone Number: 6048755094
- Email: karan.dsouza@alumni.ubc.ca
-
Contact:
- Jean Philip Dawe, CD MD FRCSC
- Phone Number: 6048755094
- Email: philip.dawe@vch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Near-Infrared Fluorescence Cholangiography
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
|
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.
As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.
|
ACTIVE_COMPARATOR: White Light Imaging
Standard laparoscopic cholecystectomy completed with only standard white light imaging only
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As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate of extrahepatic biliary structures
Time Frame: Intraoperatively
|
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).
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Intraoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative success
Time Frame: Intraoperatively
|
Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.
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Intraoperatively
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Rates of conversion
Time Frame: Intraoperatively
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Rate of conversion to open cholecystectomy.
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Intraoperatively
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Operative time
Time Frame: Intraoperatively
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From the time of opening the skin to the time of closure.
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Intraoperatively
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Surgeon satisfaction
Time Frame: Through participant discharge, an average of 1 week
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Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.
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Through participant discharge, an average of 1 week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: Through participant discharge, an average of 1 week
|
Any adverse events associated with the administration or use of ICG fluorescent cholangiography
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Through participant discharge, an average of 1 week
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Procedural complications
Time Frame: Through participant discharge, an average of 1 week
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Any complications associated with the cholecystectomy
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Through participant discharge, an average of 1 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Philip Dawe, CD MD FRCSC, Clinical Assistant Professor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pancreatic Diseases
- Bile Duct Diseases
- Common Bile Duct Diseases
- Cholecystitis
- Cholecystitis, Acute
- Gastrointestinal Diseases
- Digestive System Diseases
- Pancreatitis
- Calculi
- Cholangitis
- Gallstones
- Cholelithiasis
- Cholecystolithiasis
- Choledocholithiasis
- Gallbladder Diseases
- Biliary Tract Diseases
- Pathological Conditions, Anatomical
Other Study ID Numbers
- H21-01375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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