Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Sant Joan Despí, Barcelona, 08970, Spain
Location status: Recruiting
NCT Number: NCT07400237
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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Request Info18 year and older
All sexes
Interventional
Not applicable
Sant Joan Despí, Barcelona, 08970, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Andrea Sanz LLorente, M.D.
CONTACT
Sergio González Martínez, M.D., Ph.D.
CONTACT
Consorci Sanitari Integral
Other
Laparoscopic Ultrasound Versus Fluorescence Cholangiography in Technically Challenging Laparoscopic Cholecystectomy. Multicenter Comparative Study
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