An observational study in Kidney Cancer and Renal Neoplasms, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Observational
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.
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.
969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 100 is below the median of 211 across 215 observational studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population of interest comprises all patients undergoing RAPN for renal mass.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Also known as: robotic partial nephrectomy, RAPN, RPN
cumulative incidence of recurrences
cumulative incidence of tumor local recurrences (at surgery site)
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of Metastases
cumulative incidence of tumor distant 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
Cumulative incidence of cancer-related deaths (deaths due to the disease). This will be evaluated through cancer-specific survival (CSS)
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of All-cause Deaths
Cumulative incidence of non-cancer-related deaths (deaths due to other cause) disease). This will be evaluated through overall survival (OS)
Time frame: From date of enrolment until the date of first documented event, assessed up to 60 months
Timing of tumor rupture
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).
Time frame: During surgery
type of tumor rupture
Will evaluate the type of rupture, focal vs. gross; with vs. without spillage of tumor cells
Time frame: During surgery
Cause of rupture
Will evaluate the cause of rupture (if it is due to the surgeon's move vs. an assistant's action)
Time frame: During surgery
Surgical instrument causing the rupture
Will evaluate which robotic instruments, or which assistant's instrument did cause the tumor rupture
Time frame: During surgery
Tumor rupture Management Strategy 1
Use of suction or other methods for controlling spillage: bagging vs. grasping
Time frame: During surgery
Tumor rupture Management Strategy 2
CO2 insufflation pressure adjustments during rupture: Yes vs. No
Time frame: During surgery
Tumor rupture Management Strategy 3
Conversion to open surgery after tumor rupture: yes vs. no
Time frame: During surgery
Tumor rupture Management Strategy 4
Conversion to radical nephrectomy after tumor rupture: Yes vs. No.
Time frame: During surgery
Plan to share: No
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliera Universitaria Integrata Verona