Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis (VIFCAL)

March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Interest of Intravenous Cholangiography With Indocyanine Green, Compared to Contrast Cholangiography, in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis: Prospective, Monocentric, Randomized Study

Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. During the surgery, intraoperative cholangiography (CPO) using a contrast product is the "gold standard" to identify the bile ducts. However CPO is performed in approximately 30% of laparoscopic cholecystectomy.

Laparoscopic cholecystectomy for ALC is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. Its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults patient (>18 years old)
  • Patients requiring laparoscopic cholecystectomy for grade 1 or 2 acute gallstone cholecystitis according to Tokyo recommendations confirmed by radiological morphological examination
  • Acute lithiasis cholecystitis (ALC) evolving for less than 5 days
  • Patients affiliated to a social security scheme

Exclusion Criteria:

  • Antecedent of biliary tract surgery
  • Antecedent of cholecystectomy
  • Contraindication to laparoscopy
  • Contraindication to surgery
  • Cholecystectomy by laparotomy out of hand
  • Grade 3 cholecystitis according to Tokyo recommendations
  • Acute alithiasis cholecystitis
  • Cirrhosis
  • Conversion for gangrenous ALC
  • Patient with an allergy to indocyanine green
  • Pregnant or lactating woman, childbearing age without effective contraception
  • Minor patient
  • Physical or psychological state that does not allow participation in the study, patient under guardianship or curatorship or patient deprived of liberty by a judicial or administrative decision (according with articles L 1121-6 and L 1121-8 of the French Public Health Code)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: indocyanine green
During the surgery, intraoperative cholangiography using indocyanine green will be performed
Procedure: laparoscopic cholecystectomy
laparoscopic cholecystectomy
Diagnostic test: systematic intraoperative cholangiography
systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)
Active Comparator: standard cpo
During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed
Procedure: laparoscopic cholecystectomy
laparoscopic cholecystectomy
Diagnostic test: systematic intraoperative cholangiography
systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of surgical procedure after Indocyanine green injection
Time Frame: day 0 = the day of the surgery

Change of surgical procedure after Indocyanine green injection compared to intraoperative cholangiography (CPO) using a contrast product as the "gold standard" to identify the bile ducts.

Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
day 0 = the day of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Time Frame: day 0 = the day of the surgery
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Time Frame: day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Time Frame: day 0 = the day of the surgery
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
day 0 = the day of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Emilie Dumange Chapuis-Roux, MD, CHU Amiens
  • Principal Investigator: Ralucar Macovei, MD, CHU Amiens
  • Principal Investigator: Baptiste Brac, MD, CHU Amiens
  • Principal Investigator: Aurélien Gracient, MD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

October 1, 2021

Study Completion (Anticipated)

November 1, 2031

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2017_843_0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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