Cholecystectomy
Conditions
Keywords
laparoscopic cholecystectomy, laparoscopic ultrasound, fluorescence cholangiography, indocyanine green, biliary injury prevention
Brief summary
This is a multicenter, prospective, interventional clinical trial designed to evaluate and compare two intraoperative imaging modalities: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection. The primary endpoint is the successful identification of the critical junction. Secondary endpoints include visualization of individual biliary structures, time to visualization, total operative time, intraoperative and postoperative complications.
Interventions
DIAGNOSTIC_TESTLaparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG)
Two intraoperative imaging modalities will be applied: laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG), for the identification of biliary anatomy in technically challenging laparoscopic cholecystectomy. All enrolled subjects will undergo both LUS and ICG during the index procedure, following a standardized sequence, in order to allow intra-subject comparison. LUS will be performed first, followed by fluorescence cholangiography prior to Calot's triangle dissection.
Sponsors
Consorci Sanitari Integral
Hospital Moisés Broggi de Sant Joan Despí, Barcelona
Hospital Clínico Universitario de Valencia
Hospital Germans Tríes i Pujol de Badalona
Hospital Joan XXIII, Tarragona
Consorcio Parc de Salut Mar, Hospital del Mar
Hospital Mutua de Terrassa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Written informed consent provided. 3. Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following: * Acute cholecystitis. * Previous cholangitis, pancreatitis, or endoscopic retrograde cholangiopancreatography. * Prior upper abdominal surgery. * Obesity (Body Mass Index ≥ 30 kg/m²).
Exclusion criteria
1. Known allergy to ICG or iodine. 2. Pregnancy or breastfeeding. 3. High risk of choledocholithiasis (ESGE guidelines). 4. Thyroid disease. 5. Suspected gallbladder malignancy. 6. ASA class IV-V. 7. Chronic kidney disease stage \> IIIb. 8. Planned open cholecystectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct | Intraoperative | This intraoperative visualization will be assessed separately for laparoscopic ultrasound (LUS) and indocyanine green fluorescence cholangiography (ICG) and recorded as a binary outcome (yes/no) for each technique in each patient using a standardized intraoperative assessment form completed by the operating surgeon. Laparoscopic ultrasound will be performed first, followed by indocyanine green fluorescence cholangiography, according to a predefined and standardized intraoperative sequence. Intraoperative photographic documentation will be obtained for each imaging modality to objectively demonstrate the visualization of the critical biliary junction. Results will be reported as the proportion of patients with successful visualization for each modality and compared using an intra-subject analysis. |
Countries
Spain
Contacts
CONTACTAndrea Sanz LLorente, M.D.
CONTACTSergio González Martínez, M.D., Ph.D.
Outcome results
None listed