Condition: Laparoscopic Cholecystectomy Surgery · Sponsor: Instituto de Investigación Biomédica de Salamanca
Introduction: This protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate. Phase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat). Objectives: Primary objective: * To analyze differences between treatment groups (standard dose 2.5 mg \>3h preoperative vs reduced dose 0.25 mg immediate preoperative 15-30 min) during laparoscopic cholecystectomy in: * Visualization of extrahepatic biliary structures * Degree of visualization * Degree of background liver fluorescence interference * Perceived utility of the technique Secondary objectives: * Influence of BMI, biliary pathology type, surgery type, prior inflammation, surgical difficulty, previous instrumentation, and laparoscopic imaging system on results * Intraoperative and postoperative complication rates * 30-day mortality * Impact on operative time and hospital stay * Correlation between subjective and objective fluorescence assessment (ducts-to-liver fluorescence ratio) Population: Patients ≥18 years indicated for laparoscopic cholecystectomy (elec…
This description comes directly from the study's public registry record.
Fátima Macho Sánchez-Simón, Project Manager · +34923291200 · uicec.admon@ibsal.es
Esperanza López Franco, PhD · +34923291200 · uicec.coordinacion@ibsal.es
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| Hospital Universitario de Salamanca | Salamanca, Salamanca, Spain | Recruiting |
| Hospital Virgen de la Concha | Zamora, Zamora, Spain | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07195331