Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cho… (NCT04103762) | Clinical Trial Compass
CompletedNot Applicable
Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis
France156 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of surgical procedure after Indocyanine green injection