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| Name | Class |
|---|---|
| Hospital Moisés Broggi de Sant Joan DespÃ, Barcelona | UNKNOWN |
| Hospital ClÃnico Universitario de Valencia | OTHER |
| Hospital Germans TrÃes i Pujol de Badalona | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex laparoscopic cholecystectomy | Other | Laparoscopic cholecystectomy with anticipated technical difficulty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic ultrasound (LUS) and fluorescence cholangiography with indocyanine green (ICG) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clear intraoperative identification of the junction between the cystic duct, the common hepatic duct, and the common bile duct | 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. | Intraoperative |
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Inclusion Criteria:
Age ≥ 18 years.
Written informed consent provided.
Indication for laparoscopic cholecystectomy with anticipated technical difficulty due to one or more of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Sanz LLorente, M.D. | Contact | +34 93 5531200 | andreasanz@uic.es | |
| Sergio González MartÃnez, M.D., Ph.D. | Contact | sergio.gonzalez@csi.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral | Recruiting | Sant Joan Despà | Barcelona | 08970 | Spain |
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| Hospital Joan XXIII, Tarragona |
| UNKNOWN |
| Consorcio Parc de Salut Mar, Hospital del Mar | UNKNOWN |
| Hospital Mutua de Terrassa | OTHER |
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