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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2024-07-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Lithiasis Cholecystitis, Acute Cholangiopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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indocyanine green

During the surgery, intraoperative cholangiography using indocyanine green will be performed

Group Type EXPERIMENTAL

laparoscopic cholecystectomy

Intervention Type PROCEDURE

laparoscopic cholecystectomy

systematic intraoperative cholangiography

Intervention Type DIAGNOSTIC_TEST

systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

standard cpo

During the surgery, intraoperative cholangiography using a contrast product "gold standard" will be performed

Group Type ACTIVE_COMPARATOR

laparoscopic cholecystectomy

Intervention Type PROCEDURE

laparoscopic cholecystectomy

systematic intraoperative cholangiography

Intervention Type DIAGNOSTIC_TEST

systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

Interventions

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laparoscopic cholecystectomy

Intervention Type PROCEDURE

systematic intraoperative cholangiography

systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No