Visualization of the Extrahepatic biliaRy Tree Trial

Choledocholithiasis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04922528
• Other study ID #: H21-01375
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: January 2023

Study information

• Verified date: June 2021
• Source: University of British Columbia
• Contact: Karan J D'Souza, MD MPH MM
• Phone: 6048755094
• Email: karan.dsouza[@]alumni.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Cholangitis
• Biliary Tract Diseases
• Calculi
• Cholangitis
• Cholecystitis
• Cholecystitis, Acute
• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Digestive System Disease
• Digestive System Diseases
• Gallbladder Diseases
• Gallstone Pancreatitis
• Gallstones
• Gastrointestinal Diseases
• Pancreatitis
• Pathological Conditions, Anatomical

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Any adverse events associated with the administration or use of ICG fluorescent cholangiography	Through participant discharge, an average of 1 week
Other	Procedural complications	Any complications associated with the cholecystectomy	Through participant discharge, an average of 1 week
Primary	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).	Intraoperatively
Secondary	Operative success	Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.	Intraoperatively
Secondary	Rates of conversion	Rate of conversion to open cholecystectomy.	Intraoperatively
Secondary	Operative time	From the time of opening the skin to the time of closure.	Intraoperatively
Secondary	Surgeon satisfaction	Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.	Through participant discharge, an average of 1 week