Using Indocyanine Green to Improve Surgery for Acute Cholecystitis
INDURG TRIAL: A Randomized Controlled Trial Using Indocyanine Green During Cholecystectomy in Acute Cholecystitis
This study is testing if using a special dye during gallbladder surgery can help doctors see better and make the surgery safer for people with acute cholecystitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Corporacion Parc Tauli Academic / other |
| Locations | 2 sites (Sabadell, Barcelona and 1 other locations) |
| Trial ID | NCT05709548 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of indocyanine green in enhancing laparoscopic cholecystectomy for patients with acute cholecystitis. It compares standard surgical techniques with those that incorporate fluorescence cholangiography to improve visualization of biliary structures. The study involves a randomized, controlled design with two groups: one receiving indocyanine green and the other undergoing conventional surgery. The primary goal is to assess whether this approach reduces operating time and complications associated with bile duct injuries.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require urgent laparoscopic cholecystectomy due to acute cholecystitis.
Not a fit: Patients who are pregnant, have severe renal failure, or have contraindications to indocyanine green or laparoscopic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more efficient surgeries for patients with acute cholecystitis.
How similar studies have performed: Previous studies have shown promising results with fluorescence cholangiography in similar surgical contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sabadell, Barcelona and 1 other locations
- Hospital Universitari Parc Tauli — Sabadell, Barcelona, Spain (Recruiting)
- Hospital de Vic — Vic, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Anna Muñoz Campaña, PhD — Hospital Universitari Parc Taulí
- Study coordinator: Anna Muñoz Campaña, PhD
- Email: amunozc@tauli.cat
- Phone: 003493 723 10 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.