[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522417":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":49,"locations":56,"responsibleParty":101,"collaborators":103,"id":106,"slug":54,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":54,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":54,"enrollmentInfo":114,"targetDuration":54,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":127,"overallStatus":58,"whyStopped":54,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lymphaticovenous anastomosis (LVA)","EXPERIMENTAL","Patients in this group will undergo lymphaticovenous anastomosis at one or more locations on the affected limb, and the procedure will be performed under local anesthesia. During the operation, patients will be blinded using a noise-canceling headphone and blindfolds. Incisions will be made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The locations will be determined prior to the surgery using ICG lymphography. The LVA(s) will be made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVA(s) is made using a surgical microscope and the operation will take approximately 60 to 90 minutes.",[13],"Procedure: Lymphaticovenous anastomosis",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham surgery","SHAM_COMPARATOR","Patients in this group will undergo sham surgery at one location on the affected limb, and the procedure will be performed under local anesthesia. During the operation, patients will be blinded using a noise-canceling headphone and blindfolds. The locations for LVA surgery will be determined prior to the surgery using ICG lymphography. However, the incision for the sham procedure will be made 2 centimeters medial or lateral to the predetermined site. This is done in order to avoid damage to the lymph vessels as to allow for future LVA surgery. After the incision, no LVA is made. Rather than performing the actual operation, the plastic surgeon will simulate the procedure by applying pressure in the surgical area. To mimic the approximate duration of a regular LVA procedure, the sham operation will take approximately 60 to 90 minutes.",[19],"Procedure: Sham surgery",[21,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Lymphaticovenous anastomosis","Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema",[9],[27,28,29,30],"LVA","Lymphaticovenular anastomosis","Lymphovenous bypass","Lymphatic-venous shunt",{"type":22,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"Sham surgery involves the process of surgery, including local anesthesia and incisions, but no LVA is made.",[15],[35,36,37],"Placebo surgery","Simulated surgery","Surgical placebo",[39,42,46],{"name":40,"affiliation":5,"role":41},"Shan Shan Qiu Shao, MSc, PhD","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":44,"role":45},"Stefan Hummelink, MSc, PhD","Radboud University Medical Center","STUDY_CHAIR",{"name":47,"affiliation":48,"role":45},"Dalibor Vasilic, MSc, PhD","Erasmus Medical Center",[50],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Tanya Wolffenbuttel, MSc","CONTACT","+31(0)433877481",null,"t.wolffenbuttel@erasmusmc.nl\u002Ftanya.wolffenbuttel@mumc.nl",[57,74,87],{"facility":44,"status":58,"city":59,"state":60,"zip":61,"country":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Nijmegen","Gelderland","6525GA","Netherlands",{"type":64,"coordinates":65},"Point",[66,67],5.85278,51.8425,{"lat":67,"lon":66},[70,71,72],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},{"name":43,"role":41,"phone":54,"phoneExt":54,"email":54},{"name":51,"role":73,"phone":54,"phoneExt":54,"email":54},"SUB_INVESTIGATOR",{"facility":5,"status":58,"city":75,"state":76,"zip":77,"country":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Maastricht","Limburg","6229HX",{"type":64,"coordinates":79},[80,81],5.68889,50.84833,{"lat":81,"lon":80},[84,85,86],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},{"name":40,"role":41,"phone":54,"phoneExt":54,"email":54},{"name":51,"role":73,"phone":54,"phoneExt":54,"email":54},{"facility":88,"status":58,"city":89,"state":90,"zip":91,"country":62,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Erasmus University Medical Center","Rotterdam","South Holland","3015GD",{"type":64,"coordinates":93},[94,95],4.47917,51.9225,{"lat":95,"lon":94},[98,99,100],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},{"name":47,"role":41,"phone":54,"phoneExt":54,"email":54},{"name":51,"role":73,"phone":54,"phoneExt":54,"email":54},{"type":102,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR",[104,105],{"name":44,"class":6},{"name":48,"class":6},"100522417",false,"NCT06082349","The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema","Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;\n* Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;\n* Unilateral lymphedema;\n* Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);\n* Refractory lymphedema that underwent at least three months of conservative treatment;\n* Informed consent.\n\nExclusion Criteria:\n\n* History of lymphatic reconstruction in the past 10 years;\n* Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and\u002For fibrosis;\n* Patients with active distant metastases, treated with palliative intent;\n* Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and\u002For chemotherapy. Note: patients receiving adjuvant targeted and\u002For endocrine treatment are eligible;\n* Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;\n* Active infection in the lymphedematous extremity;\n* Bilateral lymphedema;\n* Lymphedema present in genital or breast area only;\n* Primary lymphedema;\n* Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).","ALL","18 Years",{"count":115,"type":116},110,"ESTIMATED","INTERVENTIONAL",[119],"NA","The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score.\n\nA total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.",[122,123,124,125,126],"Lymphedema, Secondary","Lymphedema of Upper Limb","Lymphedema, Lower Limb","Lymphedema Arm","Lymphedema of Leg",[23,15,128,27],"Microsurgery","2026-01-15",{"date":131,"type":132},"2026-01-16","ACTUAL",{"date":134,"type":132},"2023-12-18",{"date":136,"type":116},"2029-03-01",{"name":5,"class":6},3]