Clinical trial · Observational
Tumor Rupture During Robotic Partial Nephrectomy
A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Neoplasms | Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| robot-assisted partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients who experienced tumor rupture during robotic partial nephrectomy
- description
- Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection)
- interventionNames
- Procedure: robot-assisted partial nephrectomy
Primary outcomes (4)
- measure
- cumulative incidence of recurrences
- timeFrame
- From date of enrolment until the date of first documented event, assessed up to 60 months
- description
- cumulative incidence of tumor local recurrences (at surgery site)
- measure
- Cumulative incidence of Metastases
- timeFrame
- From date of enrolment until the date of first documented event, assessed up to 60 months
- description
- cumulative incidence of tumor distant metastases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection) * Patients who provide informed consent to participate * Patients from 18 to 80 years of age. Exclusion Criteria: * Patients undergoing radical nephrectomy or other nephron-sparing procedures. * Patients undergoing partial nephrectomy with other approaches (open, pure laparoscopic) * Patients with multiple ipsilateral tumors * Patients diagnosed with genetic abnormalities that increase the likelihood of developing renal cell carcinoma. * Patients who deny consent.
References
Publications (2)
- BACKGROUNDXu P, Zhang S, Cao B, Huang J, Li Y, Cheng J, Lin W, Cheng J, Chen W, Zhu Y, Jiang S, Hu X, Guo J, Wang H. Does intraoperative cyst rupture of malignant cystic renal masses really have no negative impact on oncologic outcomes? World J Surg Oncol. 2022 Nov 25;20(1):369. doi: 10.1186/s12957-022-02824-7. PMID 36434718
- BACKGROUNDBertolo R, Campi R, Amparore D; European Association of Urology (EAU) Young Academic Urologists (YAU) Renal Cancer Working Group. YAU renal cancer SPOTLIGHT: the understated challenge of tumor rupture during robotic partial nephrectomy. Minerva Urol Nephrol. 2025 Jun;77(3):417-421. doi: 10.23736/S2724-6051.25.06509-7. No abstract available. PMID 40528779