Authorised Therapeutic use (Phase IV) Emergency cholecystectomy is the gold standard treatment for acute cholecystitis. The procedure is feasible but carries a higher risk of iatrogenic injury to the bile duct, which should be considered preventable. Intraoperative fluorescence cholangiography following injection of indocyanine green (ICG) has been reported to aid identification of the extrahepatic bile duct.

Multicentric trial for the use of indocianine green in patients with acute cholecistitiswho needs urgent surgery.

EU CTIS ID: 2024-518677-34-00

What this study is testing

The preoperative administration of indocyanine green in urgent cholecystectomy for acute cholecystitis reduces surgical time by at least 10 minutes compared to conventional laparoscopic cholecystectomy.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology.
  • Older than 18 years.
  • Patients who have read the study information sheet and signed the informed consent sheet.

You likely can't join if

  • Pregnant or breastfeeding patients.
  • Grade IV renal failure or patients on dialysis.
  • Patients with previous hypersensitivity to indocyanine green.
  • Patients with allergy to iodinated contrast
  • Patients with clinical hyperthyroidism, autonomic thyroid adenomas, and focal and diffuse autonomic abnormalities of the thyroid gland.
  • Contraindication to laparoscopic surgery.
See the full eligibility criteria
Who can join
  • Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology.
  • Older than 18 years.
  • Patients who have read the study information sheet and signed the informed consent sheet.
What rules you out
  • Pregnant or breastfeeding patients.
  • Grade IV renal failure or patients on dialysis.
  • Patients with previous hypersensitivity to indocyanine green.
  • Patients with allergy to iodinated contrast
  • Patients with clinical hyperthyroidism, autonomic thyroid adenomas, and focal and diffuse autonomic abnormalities of the thyroid gland.
  • Contraindication to laparoscopic surgery.
  • Suspicion of choledocholithiasi.
  • Pediatric patients under 18 years of age.
  • Patients refusing to participate in the study.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.