German National Registry for NSS

Recruiting

• Conditions: Kidney Neoplasm

• Registration Number: NCT04681690
• Lead Sponsor: Association of Urologic Oncology (AUO)

Brief Summary

The G-NeSS Registry prospectively collects data on clinical and outcome variables from patients undergoing partial nephrectomy for renal masses. Analyses of data aims at identifying key factors determining the quality of surgical care in this patient population.

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.

Study Timeline

• Study First Submitted: 2020-09-09
• Study Start: 2020-12-15
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-09-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication rate	60 months	Complication rate according to Clavien-Dindo in %
Postoperative glomerular inflitration rate	60 months	Rate in ml/min.
Survival	60 months	Overall Survival

Trial Locations

Locations (5)

Sana Klinikum Hof; 🇩🇪 Hof, Bavaria, Germany

Alexianer St. Hedwig-Krankenhaus; 🇩🇪 Berlin, Germany

MHH; 🇩🇪 Hannover, Niedersachsen, Germany

Vivantes Humboldt Klinikum; 🇩🇪 Berlin, Germany

Saarland University; 🇩🇪 Homburg/Saar, Germany