Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis (VIFCAL)
Primary Purpose
Lithiasis, Cholecystitis, Acute, Cholangiopathy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
systematic intraoperative cholangiography
Sponsored by
About this trial
This is an interventional treatment trial for Lithiasis focused on measuring acute lithiasis cholecystitis, intraoperative cholangiography, indocyanine green, cholecystectomy
Eligibility Criteria
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)
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
indocyanine green
standard cpo
Arm Description
During the surgery, intraoperative cholangiography using indocyanine green will be performed
During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed
Outcomes
Primary Outcome Measures
Change of surgical procedure after Indocyanine green injection
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.
Secondary Outcome Measures
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Full Information
NCT ID
NCT04103762
First Posted
September 19, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04103762
Brief Title
Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis
Acronym
VIFCAL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lithiasis, Cholecystitis, Acute, Cholangiopathy
Keywords
acute lithiasis cholecystitis, intraoperative cholangiography, indocyanine green, cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
indocyanine green
Arm Type
Experimental
Arm Description
During the surgery, intraoperative cholangiography using indocyanine green will be performed
Arm Title
standard cpo
Arm Type
Active Comparator
Arm Description
During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Intervention Description
laparoscopic cholecystectomy
Intervention Type
Diagnostic Test
Intervention Name(s)
systematic intraoperative cholangiography
Intervention Description
systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)
Primary Outcome Measure Information:
Title
Change of surgical procedure after Indocyanine green injection
Description
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.
Time Frame
day 0 = the day of the surgery
Secondary Outcome Measure Information:
Title
Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green
Description
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
Title
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection
Description
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
Title
Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc Regimbeau, Pr
Phone
(33)322088893
Email
regimbeau.jean.marc@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama ABOU ARAB, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilie Dumange Chapuis-Roux, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralucar Macovei, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Baptiste Brac, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aurélien Gracient, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Regimbeau, Pr
Phone
(33)322088893
Email
regimbeau.jean-marc@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis
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