Tumor Rupture During Robotic Partial Nephrectomy

Summary

The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear.

The study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed.

By analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.

Conditions

• Kidney Cancer
• Renal Neoplasms

Interventions

PROCEDURE

robot-assisted partial nephrectomy

Robotic-Assisted Partial Nephrectomy (RAPN) is a minimally invasive surgical procedure performed with the help of a robotic system to remove a kidney tumor while preserving as much healthy kidney tissue as possible. It is commonly used to treat small to medium-sized kidney tumors. Thanks to the precision of robotic technology, RAPN offers faster recovery, less postoperative pain, and fewer complications compared to traditional open surgery.

Sponsors & Collaborators

• Fundación Investigación Hospital IMED Valencia, Valencia, Spain

  collaborator UNKNOWN

• Hospital Clinic de Barcelona, Barcelona, Spain

  collaborator UNKNOWN

• The Cleveland Clinic

  collaborator OTHER

• Fundacio Puigvert

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Fox Chase Cancer Center

  collaborator OTHER

• ASST Grande Ospedale Metropolitano Niguarda

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Ospedale San Luigi Gonzaga, Orbassano

  collaborator UNKNOWN

• Changhai hospital of Navy Medical University

  collaborator UNKNOWN

• St. George's Hospital, London

  collaborator OTHER

• Frimley Health NHS Foundation Trust

  collaborator UNKNOWN

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Hospital da Luz, Lisboa

  collaborator UNKNOWN

• Swedish Medical Center

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• St. Antonius Hospital Gronau

  collaborator OTHER

• Regina Elena Cancer Institute

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Onze Lieve Vrouwziekenhuis Aalst

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• Royal Free and University College Medical School

  collaborator OTHER

• Università degli Studi del Piemonte Orientale Amedeo Avogadro

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• A.O.U. Città della Salute e della Scienza - Molinette Hospital

  collaborator OTHER

• University Medical Centre Ljubljana

  collaborator OTHER

• Azienda Ospedaliera Universitaria Integrata Verona

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2030-12-31

Completion

2030-12-31

Countries

• Italy

Study Locations