Overview
Sponsor-declared trial summary
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.
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.
Key facts
- Sponsor
- Fundacio Parc Tauli
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Trial duration
- 15 Mar 2023 → ongoing
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fundació Parc Taulí
External identifiers
- EU CT number
- 2024-518677-34-00
- EudraCT number
- 2022-003730-39
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
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.
Secondary objectives 6
- Assess intraoperative complications: vascular or biliary lesions noted intraoperatively.
- Evaluate the correct intraoperative visualization of the structures that make up the Calot Triangle after the administration of indocyanine green, which includes: cystic duct, common bile duct, and common hepatic duct, before and after dissection.
- Evaluate postoperative complications and morbidity according to the Clavien-Dindo classification and CCI (Charlson comorbidity index).
- Evaluate the postoperative hospital stay.
- Reduction of costs associated with the reduction of surgical time.
- Satisfaction of the surgeon with the visualization of the biliary anatomy after the administration of indocyanine green.
Conditions and MedDRA coding
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.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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.
Exclusion criteria 9
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Surgical time (minutes): It is defined as the time between the first incision in the skin until its closure.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP2006725 · ATC
- Active substance
- Indocyanine Green
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0.50 mg/kg milligram(s)/kilogram
- Max total dose
- 0.50 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX01 — INDOCYANINE GREEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Parc Tauli
- Sponsor organisation
- Fundacio Parc Tauli
- Address
- Santa Fe Building, Parc Del Tauli 1 Parc Del Tauli 1
- City
- Sabadell
- Postcode
- 08208
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Parc Tauli
- Contact name
- Anna Muñoz Campaña
Public contact point
- Organisation
- Fundacio Parc Tauli
- Contact name
- Anna Muñoz Campaña
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 440 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-03-15 | 2023-03-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU-CT_2024-518677-34-00_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General_ESP_for publication | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Verdye | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Spain | Acceptable 2024-11-04
|
2024-11-04 |