[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632024":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":37,"overallOfficials":45,"centralContacts":50,"locations":61,"responsibleParty":82,"collaborators":25,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":25,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":25,"enrollmentInfo":94,"targetDuration":97,"studyType":98,"phases":25,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Faculty of Medicine of Tunis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Technical feasibility","Overall SLN Detection Rate: This is defined as the proportion of patients in whom at least one SLN is identified (either pelvic or para-aortic) using the blue tracer","From the procedure to the pathology results at 4 weeks",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Negative predictive value","representing the probability that a negative SLN truly indicates that all other nodes in that drainage basin are free of disease","From the procedure till the results of pathology at 4 weeks",{"measure":19,"description":20,"timeFrame":17},"Sensitivity","The proportion of patients with node-positive disease correctly identified by the SLN technique",{"measure":22,"description":23,"timeFrame":24},"Anatomical Distribution","Analysis of where the SLNs are located","During the procedure",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","PROSPECTIVE","Patients, with an early-stage ovarian cancer ESOC (FIGO stage I \\& II), will be recruited. In our setting, the preoperative staging is based on :\n\n* MRI finding (O-RADs classification 4 OR 5)\n* Thoraco-abdominal CT scan\n* Gastrointestinal endoscopy (if needed)\n* Ovarian tumor biomarkers (CA 125, CA 19-9, Alpha-FP, HE4...) Or patients referred to our department for management of an ESOC with after an adnexectomy for ovarian mass.\n\nThese patients will receive a complete surgery for ovarian cancer : Peritoneal cytology, Bilateral adnexectomy, hysterectomy, pelvic lymphadenectomy, paraaortic lymphadenectomy, omentectomy and peritoneal biopsies.\n\nPrior to the adnexectomy, surgeon will inject in subperitoneal space of the infundibular ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal) and of the utero-ovarian ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal). Then we will wait for 15 minutes: during which we will proceed to the adnexectomy. After 15 min, the retroperitoneal space of the pelvic and para-aortic regions was opened, and the presence of Sentinelle lymph Nodes (SLNs) was examined visually. The surgeon will record the number and location of the resected SLNs. Following the identification and removal of the SLNs, a complete systematic bilateral pelvic and para-aortic lymphadenectomy is performed. All specimen will be subject to histology analysis.\n\nThe collected data:\n\n1. PreOperative informations:\n\n   * Sociodemographic data : Age, Body Mass Index, Menopausal status..\n   * History: Family history of cancer, Comorbidity, surgical history..\n   * Ovarian tumor biomarkers\n   * PreOperative imaging: MRI, CT scan, Ultrasonography\n   * Presumed FIGO stage (I or II)\n2. Peri-operative data:\n\n   * SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection\n   * Operative complications: vessel injury, nerve injury and allergic reaction to dye\n3. Pathological finding:\n\n   * tumor characterization: type (serous, mucinous,...), grade and tumor size\n   * SLN analysis: SLN frozen section, SLN final ultrastaging\n   * Non-SLN status after complete lymphadenectomy\n   * Final FIGO stage\n4. Post-operative follow-up\n\n   * Hospital stay duration\n   * Post-operative complications (within Clavien-Dindo classification)\n   * Adjuvant therapy","Patient suspected with a FIGO Stage I or II ovarain cancer ( Based on MRI and scanner finding). Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy.",[32],{"label":33,"type":25,"description":34,"interventionNames":35},"Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II )","Patients with preoperative diagnosis (Using abdominal MRI and thoraco-abdomino-pelvic scan) of early stage ovarian cancer (FIGO stage I \\& II ). Paitients with O-RADs 4 or 5 MRI ovarian tumors with or without elevated ovarian tumor markers.",[36],"Procedure: Sentinel node biopsy with patent blue dye",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"PROCEDURE","Sentinel node biopsy with patent blue dye","Sentinel lymph node using patent blue dye for early ovarian cancer",[33],[44],"sentinel lymph node biopsy using patent blue dye for early stage ovarian cancer",[46],{"name":47,"affiliation":48,"role":49},"KHALED NEJI, Professor","Maternity and neonatology center of Tunis","STUDY_CHAIR",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Mohammed Amine Hannachi, Assistant professor","CONTACT","+21699696332","+216","medaminehannachi3@gmail.com",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Khaled Neji, Professor","+21651352742","DRKHALEDNEJI21@GMAIL.COM",[62],{"facility":48,"status":63,"city":64,"state":25,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","La Rabta","1007","Tunisia","TN",{"type":69,"coordinates":70},"Point",[71,72],10.15537,36.8023,{"lat":72,"lon":71},[75,78,79],{"name":76,"role":53,"phone":77,"phoneExt":25,"email":56},"Hannachi Amine","99696332",{"name":25,"role":53,"phone":25,"phoneExt":25,"email":56},{"name":80,"role":81,"phone":25,"phoneExt":25,"email":25},"Hannachi M Mohammed Amine, Assistant Professor","PRINCIPAL_INVESTIGATOR",{"type":81,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mohammed Amine HANNACHI","Assistant Professor","100632024","patent-blue-sln-in-early-ovarian-cancer-prospective-study-figo-i-ii-evaluating-patent-blue-sln-mapping-injection-into-ipuo-ligaments-in-situ-goals-assess-feasibility-and-accuracy-vs-standard-lymphadenectomy-to-minimize-surgical-morbidity-100632024",false,"NCT07508306","Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP\u002FUO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity","Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study","Inclusion Criteria:\n\n* Age : aged 18 years-old or older\n* Diagnosis: Suspected Ovarian cancer on MRI finding (O-RADs 4 or 5)\n* FIGO stage: Stage I or II ( Based on MRI and scanner finding)\n* Planned Procedure: Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy\n* Consent: Signing of the written informed consent after full information has been provided\n\nExclusion Criteria:\n\n* Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm).\n* Disease extension: Radiological or intraoperative evidence of extra-pelvic metastases or peritoneal carcinomatosis.\n* Surgical history: History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or the iliac vessels.\n* History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy.\n* Allergies: Known allergy or adverse reaction to patent blue dyes.","FEMALE","18 Years",{"count":95,"type":96},30,"ESTIMATED","6 Months","OBSERVATIONAL","the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy.\n\nHowever, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic.\n\nIn our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet.\n\nDuring surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care.\n\nOur objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.",[101,102],"Sentinel Lymph Node Biopsy (SLNB)","Early Stage Ovarian Tumors",[104,105,106,107],"early stage ovarian cancer","sentinel lymph node","sentinel lymph node biopsy","Patent blue dye","2026-09-07",{"date":110,"type":111},"2026-09-10","ACTUAL",{"date":113,"type":111},"2026-04-15",{"date":115,"type":96},"2028-02-28",{"name":5,"class":6},1]