Clinical trial • Phase IV • Gastroenterology
INDOCYANINE GREEN for Acute cholecystitis
Phase IV trial of INDOCYANINE GREEN for Acute cholecystitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Acute cholecystitis
- Trial Stage
- Phase IV
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 04-11-2024
Trial design
Randomised, conventional laparoscopic cholecystectomy (no indocyanine green). no drug dose or schedule specified for comparator.-controlled Phase IV trial across 5 sites in Spain.
- Randomised
- Yes
- Comparator
- Conventional laparoscopic cholecystectomy (no indocyanine green). No drug dose or schedule specified for comparator.
- Target Sample Size
- 440
Eligibility
Recruits 440 No vulnerable populations selected. Participants must be older than 18 years and must have read the study information sheet and signed the informed consent form; pediatric patients under 18 are explicitly excluded..
- Pregnancy Exclusion
- Pregnant or breastfeeding patients.
- Vulnerable Population
- No vulnerable populations selected. Participants must be older than 18 years and must have read the study information sheet and signed the informed consent form; pediatric patients under 18 are explicitly excluded.
Inclusion criteria
- {"criterion_text":"- Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology.\n- Older than 18 years.\n- Patients who have read the study information sheet and signed the informed consent sheet."}
Exclusion criteria
- {"criterion_text":"- Pregnant or breastfeeding patients.\n- Grade IV renal failure or patients on dialysis.\n- Patients with previous hypersensitivity to indocyanine green.\n- Patients with allergy to iodinated contrast\n- Patients with clinical hyperthyroidism, autonomic thyroid adenomas, and focal and diffuse autonomic abnormalities of the thyroid gland.\n- Contraindication to laparoscopic surgery.\n- Suspicion of choledocholithiasi.\n- Pediatric patients under 18 years of age.\n- Patients refusing to participate in the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Surgical time (minutes): It is defined as the time between the first incision in the skin until its closure.","definition_or_measurement_approach":"Defined as the time between the first incision in the skin until its closure."}
Recruitment
- Planned Sample Size
- 440
- Recruitment Window Months
- 35
- Consent Approach
- Participants must be older than 18, must read the study information sheet and sign the informed consent form. The subject information and informed consent form document available in the dossier: 'L1_SIS and ICF General_ESP_for publication' (Spanish). No assent process described; pediatric patients are excluded.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 440
Spain
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 04-11-2024
- Processing Time Days
- 5
- Number Of Sites
- 5
- Number Of Participants
- 440
Sites
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- General and Digestive System Surgery
- Principal Investigator Name
- Anna Muñoz Campaña
- Principal Investigator Email
- lannavioli@gmail.com
- Contact Person Name
- Anna Muñoz Campaña
- Contact Person Email
- lannavioli@gmail.com
- Site Name
- Consorci Sanitari Del Maresme
- Department Name
- General and Digestive Surgery
- Principal Investigator Name
- Sandra López
- Principal Investigator Email
- sandra.lopezgordo@gmail.com
- Contact Person Name
- Sandra López
- Contact Person Email
- sandra.lopezgordo@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- General and Digestive System Surgery
- Principal Investigator Name
- Enrico Marrano
- Principal Investigator Email
- dott.e.marrano@gmail.com
- Contact Person Name
- Enrico Marrano
- Contact Person Email
- dott.e.marrano@gmail.com
- Site Name
- Hospital Del Mar
- Department Name
- General and Digestive System Surgery
- Principal Investigator Name
- Ana María González Castillo
- Principal Investigator Email
- 62187@parcdesalutmar.cat
- Contact Person Name
- Ana María González Castillo
- Contact Person Email
- 62187@parcdesalutmar.cat
- Site Name
- Consorci Hospitalari de Vic
- Department Name
- General and Digestive System Surgery
- Principal Investigator Name
- Raquel Lobato Gil
- Principal Investigator Email
- raquellobatogil@gmail.com
- Contact Person Name
- Raquel Lobato Gil
- Contact Person Email
- raquellobatogil@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacio Parc Tauli
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- INDOCYANINE GREEN
- Active Substance
- INDOCYANINE GREEN
- Modality
- Diagnostic agent
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Starting Dose
- 0.50 mg/kg
- Dose Levels
- 0.50 mg/kg
- Frequency
- Single preoperative administration
- Maximum Dose
- 0.50 mg/kg
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