Tumor Rupture During Robotic Partial Nephrectomy

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.

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.