Use of Indocyanine Green in Acute Cholecystitis

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries. However, it can be technically complex in those patients diagnosed with acute cholecystitis who present severe inflammation or fibrosis, with bile duct injury being one of its main complications. The use of fluorescence cholangiography through the use of indocyanine green allows the identification of extrahepatic biliary structures, facilitating dissection and reducing the risk of bile duct lesions. Better visualization of the bile duct allows reducing the conversion rate to open surgery, as well as operating time.

The main objective is to assess a decrease in operating time in acute cholecystitis undergoing emergency surgery, to which indocyanine green is administered preoperatively.

Randomized, prospective, controlled, multicenter clinical trial of two groups of patients diagnosed with acute cholecystitis and requiring urgent cholecystectomy. The control group includes 220 patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green, and the intervention group includes 220 patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.

Study led by the Parc Taulí University Hospital in Sabadell.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corporacion Parc Tauli

Criteria

Inclusion Criteria:

• Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology.

• Age over 18 years.

• Patients who have read the study information sheet and signed the informed consent sheet.

Exclusion Criteria:

• 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 choledocholithiasis

• Pediatric patients under 18 years of age.

• Patients who refused to participate in the study