Use of Indocyanine Green in Acute Cholecystitis

Phase 4

Recruiting

• Conditions: Bile Duct Injury; Acute Cholecystitis
• Interventions: Drug: Indocyanine green

• Registration Number: NCT05709548
• Lead Sponsor: Corporacion Parc Tauli

Brief 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.

Detailed Description

Prospective, controlled, randomized and multicenter clinical trial comparing conventional laparoscopic cholecystectomy versus laparoscopic cholecystectomy with preoperative indocyanine green administration in patients with an indication for urgent cholecystectomy due to acute cholecystitis (of any etiology), at the Parc Taulí University Hospital and at the Germans Trias i Pujol University Hospital.

Parallel group randomization (1:1) will be performed by opening sealed envelopes, with random assignment between the two groups (intervention and control). The same number of envelopes will be assigned to the study and control group, all of them sealed and placed at random.

A four-port laparoscopic cholecystectomy will be performed by a team of surgeons with extensive experience in emergency and/or hepatobiliopancreatic surgery, according to standard techniques and safety measures.

Randomization will be carried out at the time of the indication for surgery, after acceptance and signing of the informed consent once all the inclusion criteria are met.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-02
• Study Start: 2023-03-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Indocyanine green	Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.

Primary Outcome Measures

Name	Time	Method
operating time	from the beginning of the surgery to its end, up to 300 minutes	time between the start of the surgical incision and the end of surgery

Secondary Outcome Measures

Name	Time	Method
intraoperative complications	during surgical time	surgical injuries during surgery
postoperative morbidity	in the first 30 days after surgery	complications evidenced in the postoperative period
admission days	length of hospital stay, from admission to discharge, up to 3 month	days of hospital admission
visualization of biliary anatomy with indocyanine green	during surgical time	Evidence the correct visualization of the biliary structures after the administration of indocyanine green

Trial Locations

Locations (2)

Hospital de Vic; 🇪🇸 Vic, Barcelona, Spain

Hospital Universitari Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain