Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-09-30
2030-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients who experienced tumor rupture during robotic partial nephrectomy
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)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who provide informed consent to participate
* Patients from 18 to 80 years of age.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Fundación Investigación Hospital IMED Valencia, Valencia, Spain
UNKNOWN
Hospital Clinic de Barcelona, Barcelona, Spain
UNKNOWN
The Cleveland Clinic
OTHER
Fundacio Puigvert
OTHER
San Raffaele University Hospital, Italy
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
University Hospital, Bordeaux
OTHER
Fox Chase Cancer Center
OTHER
ASST Grande Ospedale Metropolitano Niguarda
OTHER
Azienda Ospedaliero-Universitaria Careggi
OTHER
Ospedale San Luigi Gonzaga, Orbassano
UNKNOWN
Changhai hospital of Navy Medical University
UNKNOWN
St. George's Hospital, London
OTHER
Frimley Health NHS Foundation Trust
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Rennes University Hospital
OTHER
University of Illinois at Chicago
OTHER
University of California, San Diego
OTHER
Hospital da Luz, Lisboa
UNKNOWN
Swedish Medical Center
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
St. Antonius Hospital Gronau
OTHER
Regina Elena Cancer Institute
OTHER
Pitié-Salpêtrière Hospital
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Onze Lieve Vrouwziekenhuis Aalst
OTHER
Hannover Medical School
OTHER
Royal Free and University College Medical School
OTHER
Università degli Studi del Piemonte Orientale Amedeo Avogadro
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
The Netherlands Cancer Institute
OTHER
A.O.U. Città della Salute e della Scienza - Molinette Hospital
OTHER
University Medical Centre Ljubljana
OTHER
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Locations
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AOUI Verona
Verona, , Italy
Countries
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Facility Contacts
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References
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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.
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.
Other Identifiers
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674CET
Identifier Type: -
Identifier Source: org_study_id
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