Tumor Rupture During Robotic Partial Nephrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: robot-assisted partial nephrectomy.
- Who it may be relevant to
- Registry conditions: Kidney Cancer, Renal Neoplasms. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis
Overview
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.
Detailed description
Background Robotic-assisted partial nephrectomy (RAPN) is a common, minimally invasive surgery used to remove kidney tumors while preserving healthy kidney tissue. While generally safe and effective, a complication called tumor rupture may occasionally occur. This means the tumor capsule (its outer layer) breaks during surgery, sometimes causing cancer cells to spill into the body. Although reported in up to 15% of surgeries, tumor rupture is not well understood, and its impact on long-term cancer outcomes remains unclear.
Purpose of the Study
This study, called the RUPTURE Project, aims to better understand tumor rupture during RAPN by answering key questions:
Does tumor rupture affect cancer recurrence or survival?
What causes it?
How can it be effectively managed during surgery?
How the Study Works This is a retro-prospective observational study, meaning it collects and analyzes both past and future cases of tumor rupture during RAPN. It involves multiple hospitals and surgical centers.
Who Can Participate? The study includes adult patients (18-80 years) who experienced a tumor rupture during RAPN and agree to participate. It excludes patients who had a radical nephrectomy (complete kidney removal), underwent open or laparoscopic surgery instead of robotic surgery, or had other complex medical conditions affecting the kidneys.
What Data Is Collected?
No additional procedures are required beyond standard clinical care. The study gathers information about:
Patient characteristics (age, health status, kidney function)
Tumor characteristics (size, location, type)
Surgical details (how the rupture occurred, surgical tools used, and how the situation was managed)
Pathological analysis (tumor grade, stage, margins)
Follow-up outcomes, including:
Local recurrence of the tumor
Spread (metastasis) to other parts of the body
Cancer-related and all-cause survival over a 5-year period
Why This Study Matters
Currently, there are no standardized guidelines for managing tumor rupture during kidney surgery. The RUPTURE Project will provide essential information to help:
Predict when and why ruptures occur
Guide surgeons on best practices during rupture events
Understand the long-term impact on patient health
Impact on Patients and Health Providers
The results of this study could lead to:
Safer surgeries with fewer complications
Improved guidelines for managing tumor rupture
Better information for patients facing kidney surgery
Potential changes in how surgeons plan and respond to complications
Study Duration The study will collect data over 2 years and follow up with patients for at least 5 years. A total of 100 or more cases of tumor rupture are expected to be analyzed across multiple centers.
Ethical and Privacy Considerations Participation is voluntary, and all patient data is handled confidentially, in compliance with European and Italian privacy laws (GDPR and national regulations). No experimental treatments or changes to care are made-this is strictly an observational study.
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.
Primary outcome measures
- cumulative incidence of recurrences [Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months]
- Cumulative incidence of Metastases [Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months]
- Cumulative incidence of Cancer-related Deaths [Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months]
- Cumulative incidence of All-cause Deaths [Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months]
Secondary outcome measures (4)
- Timing of tumor rupture [Time frame: During surgery]
- type of tumor rupture [Time frame: During surgery]
- Cause of rupture [Time frame: During surgery]
- Surgical instrument causing the rupture [Time frame: During surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- AOUI Verona — Verona
Publications
- Xu 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
- Bertolo 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
Identifiers
NCT: NCT07065825 · 674CET