[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591503":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Hospital del Mar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic","EXPERIMENTAL","Robotic pancreatoduodenectomy is performed under the robotic da Vinci system where at least the pancreatic and biliary anastomosis is performed throughout this approach.",[13],"Procedure: Robotic pancreatoduodenectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Open","ACTIVE_COMPARATOR","open pancreatoduodenectomy is performed through a laparotomy following the standard criteria for this type of surgery.",[19],"Procedure: open pancreatoduodenectomy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Robotic pancreatoduodenectomy","A Robotic approach pancreatoduodenectomy is performed on patients",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"open pancreatoduodenectomy","An open approach for pancreatoduodenectomy is performed",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Benedetto Ielpo, PhD, MD, FACS, FEBS","CONTACT","0034 932 48 30 00","bielpo@hmar.cat",[38],{"facility":5,"status":26,"city":39,"state":26,"zip":26,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Barcelona","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],2.15899,41.38879,{"lat":46,"lon":45},[49],{"name":50,"role":34,"phone":35,"phoneExt":26,"email":36},"IBenedetto Ielpo, MD, PhD, FACS, FEBS",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Benedetto Ielpo","prof","100591503","robotic-vs-open-pancreatoduodenectomy-100591503",false,"NCT06981273","Robotic vs Open Pancreatoduodenectomy","SPAIN Trial Comparing Open vs Robotic Pancreatoduodenectomy","SPAIN PD","Inclusion Criteria:\n\n* Age 18 years or older.\n* Patients requiring planned pancreatoduodenectomy (robotic or open).\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who refuse the procedure.\n* Uncertainty about vascular involvement that could affect resectability.\n* Poor general health status (American Society of Anesthesiologists \\[ASA\\] classification IV).\n* Pancreatitis","ALL","18 Years",{"count":66,"type":67},93,"ESTIMATED","INTERVENTIONAL",[70],"NA","Pancreatic surgery, specifically pancreatoduodenectomy (PD), is a complex procedure often required for patients with pancreatic or other periampullary cancers. In recent years, minimally invasive techniques have become more popular, especially robotic-assisted surgery. However, there are limited studies comparing robotic surgery to traditional open surgery.\n\nThis is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess complications within 90 days after surgery. This study is important because it will provide evidence on which approach is safer and more effective for patients.\n\nThe study follows a \\*\\*prospective, randomized, and multicenter design\\*\\*, meaning patients are assigned to either robotic or open surgery randomly, and multiple hospitals are involved. The study will include all eligible patients undergoing planned PD surgery, either by robotic or open technique.\n\nTo be included in the study, patients must meet these conditions:\n\n* Be \\*\\*18 years or older\\*\\*.\n* Require \\*\\*planned PD surgery\\*\\*.\n* Sign an \\*\\*informed consent form\\*\\*.\n\nWho Cannot Participate?\n\nPatients will \\*\\*not\\*\\* be included if they:\n\n* \\*\\*Refuse the procedure\\*\\*.\n* Have \\*\\*uncertainty about vascular involvement\\*\\*.\n* Have a severe health condition classified as \\*\\*ASA IV\\*\\* (high-risk for surgery).\n\nThe main outcome measured will be the \\*\\*Comprehensive Complication Index (CCI), a standardized way to assess post-surgical complications. Additional factors being studied include:\n\n* \\*\\*Clinical outcomes\\*\\* during and after surgery.\n* \\*\\*Quality of life\\*\\* assessments.\n* \\*\\*Surgical costs\\*\\*.\n* \\*\\*Hospital stay duration\\*\\*.\n* \\*\\*Need to switch from robotic to open surgery\\*\\*.\n* \\*\\*Need for additional surgery (reoperations)\\*\\*.\n* \\*\\*Hospital readmissions\\*\\*.\n\nWhere Is the Study Being Conducted?\n\nThe study is being conducted in \\*\\*ten major hospitals across Spain\\*\\*:\n\n1. Hospital del Mar, Barcelona\n2. Hospital Balmis, Alicante\n3. Hospital Vall d'Hebron, Barcelona\n4. Arnau de Vilanova, Lleida\n5. Joan XXIII, Tarragona\n6. Hospital Sant Pau, Barcelona\n7. Germans Trias i Pujol, Barcelona\n8. Hospital Clínic, Barcelona\n9. HM Sanchinarro, Madrid\n10. Hospital Rio Hortega, Valladolid\n\nHow Long Will the Study Last? The study will take \\*\\*two years\\*\\* to complete, and patients will be followed for \\*\\*three years\\*\\* after surgery to track long-term outcomes.\n\nWhy Is This Study Important for Patients? For patients undergoing PD, this study will provide essential information about the risks and benefits of robotic versus open surgery. The findings will help doctors determine the best surgical approach, leading to improved safety, faster recovery, and better long-term health outcomes.\n\nIf you are a patient facing this type of surgery, participating in this study could contribute to valuable medical knowledge while ensuring that you receive a carefully monitored treatment plan.",[73],"Pancreas Neoplasms",[9,75,76],"pancreaticoduodenectony","Robotic surgery","NOT_YET_RECRUITING","2025-05-19",{"date":80,"type":81},"2025-05-20","ACTUAL",{"date":83,"type":67},"2025-09-01",{"date":85,"type":67},"2027-09-01",{"name":5,"class":6},1]