NCT07065825

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
56mo left

Started Sep 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Sep 2025Dec 2030

First Submitted

Initial submission to the registry

July 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

5.3 years

First QC Date

July 2, 2025

Last Update Submit

July 11, 2025

Conditions

Kidney CancerRenal Neoplasms

Keywords

roboticrobotic surgerypartial nephrectomytumor rupturetumour rupturetumor resectionkidney cancersmall renal massrobotic partial nephrectomyrobot-assisted partial nephrectomy

Outcome Measures

Primary Outcomes (4)

  • cumulative incidence of recurrences

    cumulative incidence of tumor local recurrences (at surgery site)

    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

    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)

    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)

    From date of enrolment until the date of first documented event, assessed up to 60 months

Secondary Outcomes (4)

  • Timing of tumor rupture

    During surgery

  • type of tumor rupture

    During surgery

  • Cause of rupture

    During surgery

  • Surgical instrument causing the rupture

    During surgery

Other Outcomes (4)

  • Tumor rupture Management Strategy 1

    During surgery

  • Tumor rupture Management Strategy 2

    During surgery

  • Tumor rupture Management Strategy 3

    During surgery

  • +1 more other outcomes

Study Arms (1)

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)

Procedure: robot-assisted partial nephrectomy

Interventions

robot-assisted partial nephrectomyPROCEDURE

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
Patients who experienced tumor rupture during robotic partial nephrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of interest comprises all patients undergoing RAPN for renal mass.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUI Verona

Verona, 37120, Italy

Location

Related Publications (2)

  • 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: 36434718BACKGROUND

  • 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: 40528779BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 15, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)