[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607959":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":36,"locations":47,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":11,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Instituto de Investigación Biomédica de Salamanca","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"2.5 mg >3h before surgery","EXPERIMENTAL",null,[13],"Drug: Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.",{"label":15,"type":10,"description":11,"interventionNames":16},"0.25 mg 15-30 min before surgery",[17],"Drug: Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.","A dilution will be prepared by dissolving 25 mg of ICG in 10 mL of water for injectable solutions, yielding a concentration of 2.5 mg\u002FmL. Once the solution is prepared, 1 mL will be administered directly via a peripheral venous line in the patient's upper limb.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.","A dilution will be prepared by dissolving 25 mg of ICG in 25 mL of water for injectable solutions, yielding a concentration of 1 mg\u002FmL. Subsequently, 0.25 mL will be administered as a direct intravenous injection via a peripheral venous line in the patient's upper limb.",[15],[29,33],{"name":30,"affiliation":31,"role":32},"Jaime López, Medical Degree in Surgery","Centro Asistencial Universitario de Salamanca (CAUSA)","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Eva Alonso","Complejo Asistencial de Zamora.",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Fátima Macho Sánchez-Simón, Project Manager","CONTACT","+34923291200","55145","uicec.admon@ibsal.es",{"name":44,"role":39,"phone":40,"phoneExt":45,"email":46},"Esperanza López Franco, PhD","55144","uicec.coordinacion@ibsal.es",[48,61],{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":11},"Hospital Universitario de Salamanca","RECRUITING","Salamanca","37006","Spain","ES",{"type":56,"coordinates":57},"Point",[58,59],-5.66388,40.96882,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":64,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":11},"Hospital Virgen de la Concha","NOT_YET_RECRUITING","Zamora","49022",{"type":56,"coordinates":67},[68,69],-5.74456,41.50633,{"lat":69,"lon":68},{"type":72,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[74],{"name":75,"class":6},"Spanish Association of Surgeons (AEC)","100607959","phase-4-comparison-between-standard-and-reduced-doses-of-indocyanine-green-in-fluorescence-cholangiography-during-laparoscopic-cholecystectomy-100607959",false,"NCT07195331","Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.","Reduced Dose vs Standard Dose of Indocyanine Green in Near-infrared Fluorescence Cholangiography During Laparoscopic Cholecystectomy: a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Signed informed consent.\n* Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Pregnancy or lactation.\n* Chronic kidney disease (stage \\>IIIb).\n* ICG allergy.\n* Allergy to other iodinated contrast\n* Functional thyroid disease.\n* Emergency non-deferrable surgery.\n* Open approach.\n* Suspicion of gallbladder cancer.\n* Inability to understand the study.","ALL","18 Years",{"count":86,"type":87},122,"ESTIMATED","INTERVENTIONAL",[90],"PHASE4","Introduction:\n\nThis 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.\n\nPhase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat).\n\nObjectives:\n\nPrimary objective:\n\n* 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:\n* Visualization of extrahepatic biliary structures\n* Degree of visualization\n* Degree of background liver fluorescence interference\n* Perceived utility of the technique\n\nSecondary objectives:\n\n* Influence of BMI, biliary pathology type, surgery type, prior inflammation, surgical difficulty, previous instrumentation, and laparoscopic imaging system on results\n* Intraoperative and postoperative complication rates\n* 30-day mortality\n* Impact on operative time and hospital stay\n* Correlation between subjective and objective fluorescence assessment (ducts-to-liver fluorescence ratio) Population: Patients ≥18 years indicated for laparoscopic cholecystectomy (elective, early or urgent deferred).\n\nMain inclusion criteria:\n\n* Age ≥18 years\n* Signed informed consent\n* Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis, gallbladder polyps with surgical indication)\n\nMain exclusion criteria:\n\n* Age \\\u003C18 years\n* Pregnancy or lactation\n* Chronic kidney disease (stage \\>IIIb)\n* ICG or iodinated contrast allergy\n* Functional thyroid disease\n* Emergency non-deferrable surgery\n* Open approach\n* Suspicion of gallbladder carcinoma\n* Inability to understand the study Investigational product: Indocyanine green (ICG), intravenous administration\n\nThis multicenter study involves two hospitals in Castilla y León, Spain, and plans to enroll 122 adult patients meeting specific clinical criteria for LC. Participants will be randomized into two treatment arms and will receive ICG accordingly:\n\n* Group 1: 2.5 mg \\>3h before surgery\n* Group 2: 0.25 mg 15-30 min before surgery Fluorescence will be assessed both subjectively by the surgical team and objectively through digital image analysis using specialized software to calculate the bile duct-to-liver fluorescence ratio (RFBH).\n\nEndpoints:\n\n* Rates and degree of biliary structure identification pre- and post-dissection\n* Perceived utility of cholangiography\n* Liver background fluorescence interference\n* Ducts-to-liver fluorescence ratio Duration: 12 months recruitment + 1 month follow-up = total 13 months Countries: Spain Ethics: The study will be conducted in accordance with ICH-GCP, EU Clinical Trials Regulation No 536\u002F2014, and applicable national regulations.\n\nBeyond comparing the diagnostic performance of two dosing strategies, this study seeks to provide evidence supporting a more practical and logistically feasible approach for implementing ICG fluorescence cholangiography in routine surgical practice, without compromising diagnostic accuracy or patient safety.",[93],"Laparoscopic Cholecystectomy Surgery",[95,96,97,98],"laparoscopic cholecystectomy","bile ducts","cholangiography","indocyanine green","2026-03-06",{"date":101,"type":102},"2026-03-09","ACTUAL",{"date":104,"type":102},"2026-02-26",{"date":106,"type":87},"2027-01-31",{"name":5,"class":6},2]