[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525921":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":36,"overallOfficials":44,"centralContacts":48,"locations":58,"responsibleParty":94,"collaborators":17,"id":96,"slug":17,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":17,"enrollmentInfo":105,"targetDuration":17,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":17,"overallStatus":61,"whyStopped":17,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"AdventHealth","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Identify safety profile EUS-GJ","The severity of AEs will be determined using standard American Society of Gastrointestinal Endoscopy (ASGE) Lexicon and AGREE criteria (appendix) in the EUS-GJ group.","24 Months",[14],{"measure":15,"description":16,"timeFrame":12},"Identify safety profile for S-GJ","The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction. The main question this study aims to answer is:\n\n1\\. To compare the rates of procedure related adverse events (AE's) between patients undergoing Endoscopy Ultrasound-guided gastro-jejunostomy (EUS-GJ) and Surgical gastro-jejunostomy (S-GJ).\n\nStudy participants will be randomized into one of the two standard procedures and followed for up to 12 months post procedure for collection of outcomes related data",[26,31],{"label":27,"type":6,"description":28,"interventionNames":29},"EUS-guided gastrojejunostomy (EUS-GJ)","Patients on this arm will undergo the endoscopic procedure.",[30],"Procedure: Surgical gastrojejunostomy (S-GJ)",{"label":32,"type":6,"description":33,"interventionNames":34},"Surgical gastrojejunostomy (S-GJ)","Patients on this arm will undergo the surgical procedure.",[35],"Procedure: EUS-guided gastrojejunostomy (EUS-GJ)",[37,41],{"type":38,"name":32,"description":39,"armGroupLabels":40,"otherNames":17},"PROCEDURE","Surgical gastro-jejunostomy",[27],{"type":38,"name":27,"description":42,"armGroupLabels":43,"otherNames":17},"Endoscopic Ultrasound guided gastro-jejunostomy",[32],[45],{"name":46,"affiliation":5,"role":47},"Kambiz Kadkhodayan, MD","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":17,"email":53},"Diana Paredes","CONTACT","(407)303-9736","Diana.Paredes@adventhealth.com",{"name":55,"role":51,"phone":56,"phoneExt":17,"email":57},"Petronio Martins","(407)303-5503","Petronio.martins@adventhealth.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"AdventHealth Orlando","RECRUITING","Orlando","Florida","32804","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-81.37924,28.53834,{"lat":71,"lon":70},[74,78,82,83,86,88,90,92],{"name":75,"role":51,"phone":76,"phoneExt":17,"email":77},"Diana Paredes, RN","(407) 303-9736","Diana.Paredes@adventHealth.com",{"name":79,"role":51,"phone":80,"phoneExt":17,"email":81},"Petronio Martins, MHA","(407) 303-5503","Petronio.Martins@AdventHealth.com",{"name":46,"role":47,"phone":17,"phoneExt":17,"email":17},{"name":84,"role":85,"phone":17,"phoneExt":17,"email":17},"Dennis Yang, MD","SUB_INVESTIGATOR",{"name":87,"role":85,"phone":17,"phoneExt":17,"email":17},"Natalie Cosgrove, MD",{"name":89,"role":85,"phone":17,"phoneExt":17,"email":17},"Deepanshu Jain, MD",{"name":91,"role":85,"phone":17,"phoneExt":17,"email":17},"Sebastian De La Fuente, MD",{"name":93,"role":85,"phone":17,"phoneExt":17,"email":17},"Armando Rosales, MD",{"type":95,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100525921",false,"NCT06128018","Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.","A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction","RESTORE","Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.\n3. GOOSS of 0 or 1\n4. BOTH surgical and endoscopic GJ are technically and clinically feasible\n5. Can understand and is willing to sign informed consent form prior to the initiation of any study procedures (or when applicable the subject's LAR).\n\nExclusion Criteria:\n\n1. \\\u003C 18 years of age\n2. ECOG \\>2\n3. Expected survival (determined by the treating oncologist) is less than 2 months.\n4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)\n5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy\n6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)\n7. Anatomical factors that technically hinder EUS-GJ OR Surgical-GJ (diffuse tumor involvement in path of LAMS or surgery, surgically altered anatomy that interferes with the ability to perform an anastomosis etc)\n8. Pregnancy","ALL","18 Years",{"count":106,"type":107},70,"ESTIMATED","INTERVENTIONAL",[110],"NA","The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.",[113],"Malignant Gastric Outlet Obstruction","2026-04-23",{"date":116,"type":117},"2026-04-27","ACTUAL",{"date":119,"type":117},"2023-11-01",{"date":121,"type":107},"2027-03-08",{"name":5,"class":6},1]