Tumor Rupture During Robotic Partial Nephrectomy

Официальное название

A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• cumulative incidence of recurrences [Срок оценки: From date of enrolment until the date of first documented event, assessed up to 60 months]
• Cumulative incidence of Metastases [Срок оценки: From date of enrolment until the date of first documented event, assessed up to 60 months]
• Cumulative incidence of Cancer-related Deaths [Срок оценки: From date of enrolment until the date of first documented event, assessed up to 60 months]
• Cumulative incidence of All-cause Deaths [Срок оценки: From date of enrolment until the date of first documented event, assessed up to 60 months]

Вторичные конечные точки (4)

• Timing of tumor rupture [Срок оценки: During surgery]
• type of tumor rupture [Срок оценки: During surgery]
• Cause of rupture [Срок оценки: During surgery]
• Surgical instrument causing the rupture [Срок оценки: During surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• AOUI Verona — Verona

Публикации

• 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

Идентификаторы

NCT: NCT07065825 · 674CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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