[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590970":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":44,"locations":52,"responsibleParty":76,"collaborators":34,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":34,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":118,"whyStopped":34,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"King Faisal Specialist Hospital & Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Octreotide Infusion Arm","ACTIVE_COMPARATOR","Continuous intravenous octreotide (1 mcg\u002Fkg\u002Fhr) initiated at liver graft reperfusion and continued postoperatively until hemodynamic stability is achieved.",[13],"Drug: Octreotide (drug)",{"label":15,"type":10,"description":16,"interventionNames":17},"Splenic Artery Ligation (SAL) Arm","Intraoperative ligation of the splenic artery using non-absorbable suture near its origin.",[18],"Procedure: Splenic Artery Ligation (SAL)",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Octreotide (drug)","Continuous intravenous octreotide acetate infusion initiated at hepatic reperfusion during living donor liver transplantation (LDLT). The initial dose is 1 mcg\u002Fkg\u002Fhr, titrated intraoperatively based on portal venous flow (PVF) and hepatic artery flow \u002F resistive index (RI) measurements. The infusion continues postoperatively in the ICU until stable graft hemodynamics are achieved (target PVF \\\u003C5 mL\u002Fmin\u002Fg and presence of diastolic hepatic arterial flow). Dose adjustments are permitted for efficacy or safety concerns, with all modifications documented. The intervention is administered via central venous access using standard infusion protocols",[9],[26,27,28],"Octreotide acetate","Sandostatin®","Somatostatin analogue",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Splenic Artery Ligation (SAL)","Intraoperative ligation of the splenic artery performed during living donor liver transplantation (LDLT) using non-absorbable suture material (e.g., polypropylene). The ligation is typically placed near the splenic artery origin for maximal portal flow modulation, with exact positioning determined by surgeon assessment of vascular anatomy and intraoperative hemodynamics (targeting portal venous flow \\\u003C5 mL\u002Fmin\u002Fg). The procedure is performed under direct visualization during the transplant operation, with post-ligation Doppler ultrasound confirmation of hemodynamic response within 60 minutes of biliary anastomosis.",[15],null,[36,40,42],{"name":37,"affiliation":38,"role":39},"Dieter C. Broering, MD, PhD","Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":38,"role":39},"Dimitri A. Raptis, MD, MSc, PhD",{"name":43,"affiliation":38,"role":39},"Massimo Malago, MD, PhD",[45,49],{"name":37,"role":46,"phone":47,"phoneExt":34,"email":48},"CONTACT","+966 11 464 7272","dbroering@kfshrc.edu.sa",{"name":41,"role":46,"phone":50,"phoneExt":34,"email":51},"+966530330809","draptis@kfshrc.edu.sa",[53],{"facility":54,"status":34,"city":55,"state":34,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center","Riyadh","12713","Saudi Arabia","SA",{"type":60,"coordinates":61},"Point",[62,63],46.72185,24.68773,{"lat":63,"lon":62},[66,67,68,69,71,72,74],{"name":37,"role":46,"phone":47,"phoneExt":34,"email":48},{"name":41,"role":46,"phone":50,"phoneExt":34,"email":51},{"name":37,"role":39,"phone":34,"phoneExt":34,"email":34},{"name":41,"role":70,"phone":34,"phoneExt":34,"email":34},"SUB_INVESTIGATOR",{"name":43,"role":70,"phone":34,"phoneExt":34,"email":34},{"name":73,"role":70,"phone":34,"phoneExt":34,"email":34},"Kris Ann A. Marquez, BSN",{"name":75,"role":70,"phone":34,"phoneExt":34,"email":34},"Bilal Elmikkaoui, BSN",{"type":77,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100590970","phase-4-octreotide-vs-splenic-artery-ligation-for-portal-flow-modulation-in-living-donor-liver-transplants-scalop-trial-100590970",false,"NCT06974344","Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)","Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation","SCALOP","Inclusion Criteria:\n\n1. Age ≥ 18 and \\\u003C70 years\n2. Male and female genders\n3. Undergoing Living Donor Liver Transplant (LDLT)\n4. All indications\n5. Receiving a small-for-size graft requiring portal flow modulation\n6. Informed consent provided.\n\nExclusion Criteria:\n\n1. Deceased Donor Liver Transplantation (DDLT)\n2. Dual LDLT or dual LDLT\u002FDDLT\n3. Pregnancy\n4. Known allergy to Octreotide \u002F Somatostatin analogue","ALL","18 Years","70 Years",{"count":90,"type":91},80,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","The goal of this clinical trial is to compare two treatments for regulating blood flow in small liver grafts during living donor liver transplantation (LDLT). The main questions it aims to answer are:\n\n* Is octreotide (a medication) as effective or better than splenic artery ligation (surgery) in reducing complications after transplantation?\n* Which treatment better controls blood flow while causing fewer side effects?\n\nResearchers will compare octreotide (given through an IV) to splenic artery ligation (performed during surgery) to see which approach works best for patients receiving small liver grafts.\n\nParticipants will:\n\n* Be randomly assigned to receive either octreotide or splenic artery ligation during their transplant surgery\n* Have their liver blood flow monitored closely during and after surgery\n\nBe followed for 90 days and 1 year to track complications, hospital stay, recovery, and survival.\n\nThis study may help doctors choose safer, more effective treatments for patients needing small liver grafts.",[97],"Small-for-Size Syndrome",[99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,97,116,117],"Living Donor Liver Transplantation","LDLT","Small-for-Size Graft","SFS","Portal Flow Modulation","Graft Inflow Modulation","Octreotide","Somatostatin Analogue","Splenic Artery Ligation,","SAL","Randomized Controlled Trial","RCT","Complications","Outcomes","Mortality","Liver Hemodynamics","Early Allograft Dysfunction","SFSS","Survival","NOT_YET_RECRUITING","2025-05-08",{"date":121,"type":122},"2025-05-15","ACTUAL",{"date":124,"type":91},"2025-06-01",{"date":126,"type":91},"2030-09-01",{"name":5,"class":6},1]