[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592716":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":61,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Hospital Clinic of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Terminolateral anastomosis","PLACEBO_COMPARATOR","Patients assigned to this arm of intervention will have an anastomosis performed with the terminolateral anastomosis technique described in the protocol.",[13],"Procedure: Terminolateral anastomotic technique",{"label":15,"type":16,"description":17,"interventionNames":18},"Piggyback anastomosis","ACTIVE_COMPARATOR","Patients assigned to this arm of intervention will be have an anastomosis performed with the piggyback anastomosis technique described in the protocol.",[19],"Procedure: Piggyback anastomotic technique",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Terminolateral anastomotic technique","Suturing the vein and artery of the arteriovenous fistula with a terminolateral anastomotic suture.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Piggyback anastomotic technique","Suturing the vein and artery of the arteriovenous fistula with a piggyback anastomotic technique.",[15],[32],{"name":33,"affiliation":5,"role":34},"Gaspar Mestres, Medicine","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Adrián López, Medicine","CONTACT","+34 93 227 54 00","lopez74@clinic.cat",{"name":33,"role":38,"phone":39,"phoneExt":26,"email":42},"gmestres@clinic.cat",[44],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hospital Clínic de Barcelona","RECRUITING","Barcelona","08018","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],2.15899,41.38879,{"lat":55,"lon":54},[58],{"name":59,"role":38,"phone":60,"phoneExt":26,"email":40},"Adrián López, Medical Doctor","932 27 54 00",{"type":34,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Adrián López","Medical Doctor","100592716","creation-of-arteriovenous-fistulas-for-hemodialysis-using-the-end-to-side-anastomotic-technique-vs-piggyback-100592716",false,"NCT06997042","Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.","Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback. Randomized Clinical Trial","Inclusion Criteria:\n\n* Age \\> 18 years\n* Able to meet protocol requirements, including follow-up.\n* Incident or prevalent patient with advanced chronic kidney disease in the hemodialysis stage (stage 5D).\n* In predialysis patients (stage 5), if renal replacement therapy (hemodialysis) is anticipated to be required within the next 6 months (based on standard clinical criteria).\n* Who, based on their associated pathology and according to medical criteria, can withstand the initial surgery and arteriovenous access maintenance procedures.\n* Have a current ultrasound with preoperative venous and arterial mapping.\n* Meet the anatomical requirements for AVF creation:\n\n  * Wrist: artery \\>2 mm, vein \\>2 mm in diameter\n  * Elbow: artery \\>3 mm, vein \\>3 mm in diameter\n  * Absence of arterial calcification or occlusion, or other aberrant arterial anatomy.\n  * Adequate arterial and venous patency.\n  * Vein-to-skin distance \\\u003C5 mm.\n* Candidate for creation of a native arteriovenous fistula for hemodialysis, either distal (radiocephalic) or proximal (humerocephalic or humerobasilic).\n* No immediate transplant scheduled within the next 60 days (inclusion on the kidney transplant waiting list is not a contraindication for entry into the study, nor for the creation of an arteriovenous fistula).\n* No prior arteriovenous surgeries in the same or proximal location.\n* Correct understanding of the study conditions and acceptance to participate.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Life expectancy \\\u003C1 year.\n* Arteriovenous prostheses (non-native fistulas), previous arteriovenous fistula repairs, arteriovenous accesses created in the lower extremities, and unusual (exotic) accesses.\n* Known or suspected central venous stenosis\u002Focclusion on the side of the planned access.\n* Repair of previous arteriovenous accesses (proximal reanastomoses).\n* Biological immunosuppression.\n* History or evidence of serious systemic illness, including:\n\n  * Cardiac disease (New York Heart Association functional class III or IV, as evidenced by the inability to lie still), myocardial infarction within 6 weeks prior to randomization, ventricular tachyarrhythmia requiring ongoing treatment, or unstable angina.\n\nSuspected or documented hypercoagulable or hypocoagulable state or Clinically significant active infection (White blood count \\> 15,000 cells\u002Fmm3) other than the use of a treated CVC.\n\n* Any other condition that, in the investigator's judgment, prevents an adequate evaluation of the safety and efficacy of the study or poor compliance.\n* Patient unwilling or unable to attend follow-up follow-ups.","ALL","18 Years",{"count":74,"type":75},130,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study is designed to compare two surgical techniques used to create arteriovenous fistulas (AVFs), which are necessary for hemodialysis in patients with advanced chronic kidney disease (CKD). AVFs are preferred over other forms of vascular access because they last longer and have fewer complications. However, many AVFs fail to mature properly, making them unusable for dialysis.\n\nThe two techniques being studied are the traditional End-to-Side (ETS) method and a newer technique called Piggyback Straight Line Onlay Technique (pSLOT). Early studies suggest that pSLOT may reduce complications like narrowing (stenosis), clotting (thrombosis), and failure of the AVF, but more robust data from randomized clinical trials is needed.\n\nPatients aged 18 or older with stage 4 or 5 CKD, who are eligible for a new AVF and meet health criteria, may participate. During the operation, participants are randomly assigned to receive either the ETS or pSLOT technique. The procedure is done under local or regional anesthesia. Follow-up appointments are scheduled at 1 and 12 months to assess fistula maturation, blood flow, and whether it can be successfully used for dialysis. Remote follow-ups are allowed if needed.\n\nParticipation is voluntary, requires informed consent, and all data is kept strictly confidential. The study follows national and international ethical standards and has been approved by an ethics committee.",[81],"Chronic Kidney Disease Requiring Hemodialysis",[83,84,85,86],"hemodialysis","vascular access","arteriovenous fistula","piggyback","2025-09-12",{"date":89,"type":90},"2025-09-18","ACTUAL",{"date":92,"type":90},"2025-05-01",{"date":94,"type":75},"2027-12-01",{"name":5,"class":6},1]