Tumor Rupture During Robotic Partial Nephrectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAzienda Ospedaliera Universitaria Integrata Verona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The population of interest comprises all patients undergoing RAPN for renal mass.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
robot-assisted partial nephrectomy
Procedure/SurgeryRobotic-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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients who experienced tumor rupture during robotic partial nephrectomy1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 surgery2
type of tumor rupture
Will evaluate the type of rupture, focal vs. gross; with vs. without spillage of tumor cells
Time frame
During surgery3
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 surgery4
Surgical instrument causing the rupture
Will evaluate which robotic instruments, or which assistant's instrument did cause the tumor rupture
Time frame
During surgeryOther outcomes
1
Tumor rupture Management Strategy 1
Use of suction or other methods for controlling spillage: bagging vs. grasping
Time frame
During surgery2
Tumor rupture Management Strategy 2
CO2 insufflation pressure adjustments during rupture: Yes vs. No
Time frame
During surgery3
Tumor rupture Management Strategy 3
Conversion to open surgery after tumor rupture: yes vs. no
Time frame
During surgery4
Tumor rupture Management Strategy 4
Conversion to radical nephrectomy after tumor rupture: Yes vs. No.
Time frame
During surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Azienda Ospedaliera Universitaria Integrata Verona
Lead sponsor
Fundación Investigación Hospital IMED Valencia, Valencia, Spain
Collaborator
Hospital Clinic of Barcelona
Collaborator
The Cleveland Clinic
Collaborator
Fundacio Puigvert
Collaborator
San Raffaele University Hospital, Italy
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
University Hospital, Bordeaux
Collaborator
Fox Chase Cancer Center
Collaborator
ASST Grande Ospedale Metropolitano Niguarda
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Ospedale San Luigi Gonzaga, Orbassano
Collaborator
Changhai hospital of Navy Medical University
Collaborator
St. George's Hospital, London
Collaborator
Frimley Health NHS Foundation Trust
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Rennes University Hospital
Collaborator
University of Illinois at Chicago
Collaborator
University of California, San Diego
Collaborator
Hospital da Luz Lisboa, Portugal
Collaborator
Swedish Medical Center
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
St. Antonius Hospital Gronau
Collaborator
Regina Elena Cancer Institute
Collaborator
Pitié-Salpêtrière Hospital
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Onze Lieve Vrouwziekenhuis Aalst
Collaborator
Hannover Medical School
Collaborator
Royal Free and University College Medical School
Collaborator
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
The Netherlands Cancer Institute
Collaborator
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Collaborator
University Medical Centre Ljubljana
Collaborator
Source ClinicalTrials.gov
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