Tumor Rupture During Robotic Partial Nephrectomy

Not yet recruiting

• Conditions: Kidney Cancer; Renal Neoplasms

• Registration Number: NCT07065825
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Brief 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.

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-09-01
• Primary Completion: 2030-12
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of Metastases	From date of enrolment until the date of first documented event, assessed up to 60 months	cumulative incidence of tumor distant metastases
Cumulative incidence of All-cause Deaths	From date of enrolment until the date of first documented event, assessed up to 60 months	Cumulative incidence of non-cancer-related deaths (deaths due to other cause) disease). This will be evaluated through overall survival (OS)
cumulative incidence of recurrences	From date of enrolment until the date of first documented event, assessed up to 60 months	cumulative incidence of tumor local recurrences (at surgery site)
Cumulative incidence of Cancer-related Deaths	From date of enrolment until the date of first documented event, assessed up to 60 months	Cumulative incidence of cancer-related deaths (deaths due to the disease). This will be evaluated through cancer-specific survival (CSS)

Secondary Outcome Measures

Name	Time	Method
Cause of rupture	During surgery	Will evaluate the cause of rupture (if it is due to the surgeon's move vs. an assistant's action)
type of tumor rupture	During surgery	Will evaluate the type of rupture, focal vs. gross; with vs. without spillage of tumor cells
Timing of tumor rupture	During surgery	To evaluate the timing of tumor rupture (if it occurs during tumor isolation, at the early of tumor resection, almost at completion of the resection, at tumor grabbing for bagging).
Surgical instrument causing the rupture	During surgery	Will evaluate which robotic instruments, or which assistant's instrument did cause the tumor rupture

Trial Locations

Locations (1)

AOUI Verona; 🇮🇹 Verona, Italy