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.

• robot-assisted partial nephrectomy (Procedure), also known as robotic partial nephrectomy, RAPN, RPN: 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 outcomes

• 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 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 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)
• 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)

Secondary outcomes

• 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).
• type of tumor rupture [During surgery]: Will evaluate the type of rupture, focal vs. gross; with vs. without spillage of tumor cells
• 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)
• Surgical instrument causing the rupture [During surgery]: Will evaluate which robotic instruments, or which assistant's instrument did cause the tumor rupture

Other outcomes

• Tumor rupture Management Strategy 1 [During surgery]: Use of suction or other methods for controlling spillage: bagging vs. grasping
• Tumor rupture Management Strategy 2 [During surgery]: CO2 insufflation pressure adjustments during rupture: Yes vs. No
• Tumor rupture Management Strategy 3 [During surgery]: Conversion to open surgery after tumor rupture: yes vs. no
• Tumor rupture Management Strategy 4 [During surgery]: Conversion to radical nephrectomy after tumor rupture: Yes vs. No.

Sex: All, ages: 18 Years to 80 Years

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.

• 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