German National Registry for NSS
Noch nicht rekrutierend
NCT-Nummer:
NCT04681690
Studienbeginn:
Dezember 2020
Letztes Update:
23.12.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Kidney Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Association of Urologic Oncology (AUO)
Collaborator:
IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
Studienleiter
Nina Harke, Dr. Study ChairMHH
Stefan Siemer, Prof. Dr. Study ChairUniversity Saarland
Steffen Weikert, Prof. Dr. Study ChairVivantes Humboldt-Klinikum
Kontakt
Nina Harke, Dr. Kontakt: Phone: 0511/532 Phone (ext.): 36 47 E-Mail: harke.nina@mh-hannover.de» Kontaktdaten anzeigen
Heidrun Rexer Kontakt: Phone: 039827/79 677 E-Mail: GNeSS@MeckEvidence.de» Kontaktdaten anzeigen
Detailed Description: Today the majority of patients with renal tumors is diagnosed with localized disease amenable to nephron-sparing surgery (NSS). Partial nephrectomy (PN) constitutes the reference standard treatment for small renal masses according to international guidelines. Open PN ist still the predominant apporach in Germany, but the use of minimally-invasive surgery has continously increased over the last decades. Specifically, robotic surgery is on the rise and may facilitate the adoption of a minimally-invasive PN approach even in more complex renal tumours. Real world data on the outcomes of PN according to the surgical approach are limited. Data from cancer registries and health insurance databases usually lack important information an key patient und tumour characteristics, such as tumour complexity. The G-NESS registry database aims at prospectively collecting such clinical and outcome data from patients undergoing PN. Data collection includes perioperative variables on patient characteristics, tumour location and complexity, surgical approach, intra-/postoperative complications, and kidney function. Follow-up based on questionnaires is conducted after predefined intervals (i.e. 30 days, 12 months, 24 months, and 60 months) in order to receive information on long-term kidney function, comorbidities, and survival. The information received from the database can help to better define the optimal surgical care for patients with renal masses.
Inclusion Criteria: - Age ≥ 18 years - Written informed consent - Localized renal parenchymal mass amenable to nephron-sparing surgery - Adequate imaging of the abdomen (CT or MR with contrast)Exclusion Criteria: - Patient with (or suspected to have) urothelial cancer of the kidney - Prior nephron-sparing surgery on ipsilateral kidney - metastasized renal cell carcinoma
Primary outcome: 1. Complication rate (Time Frame - 60 months):Complication rate according to Clavien-Dindo in % 2. Postoperative glomerular inflitration rate (Time Frame - 60 months):Rate in ml/min. 3. Survival (Time Frame - 60 months):Overall Survival
No intervention, observation only.:Observation only
Quelle: ClinicalTrials.gov
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