INDURG TRIAL: A Randomized Controlled Trial Using Indocyanine Green During Cholecystectomy in Acute Cholecystitis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari Parc Tauli
RECRUITING
Sabadell
Hospital de Vic
RECRUITING
Vic
Contact Information
Primary
Anna Muñoz Campaña, PhD
amunozc@tauli.cat
003493 723 10 10
Backup
Coloma Moreno
cmoreno@tauli.cat
003493 723 10 10
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 440
Treatments
No_intervention: control group
patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green
Active_comparator: intervention group
Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.
Sponsors
Leads: Corporacion Parc Tauli

This content was sourced from clinicaltrials.gov