Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy

NCT06846112 | Active Not Recruiting

• 1 other identifier: RS1835/23
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

Intended to minimize ischemia during robotic partial nephrectomy (RPN) procedures "by any means possible". Before starting enucleation, the boundaries of the tumor are marked during SL-ocRPN surgery cautery. Once the tumor is removed, the resection bed is cauterized by dispensing monopolar energy with "quasi-contact" mode, and hemostasis is progressively improved.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

• Trifecta rate

  The Trifecta rate \[defined as negative surgical margins, no major complications, no \>30% glomerular filtration rate reduction\] will be assessed and used to compare outcomes in the 2 arms. Then prospectively demonstrate that sutureless (SL) ocRPN is non-inferior to RR ocRPN in terms of surgical outcome.

  36 months

Other Outcomes (1)

• Direct costs

  36 months

Study Arms (2)

RR-ocRPN

EXPERIMENTAL

Subjects assigned to group A will receive surgical treatment through robotic partial nephrectomy (RPN), through an off-clamp and sutureless approach (SL)

Procedure: Robotic partial nephrectomy

SL-ocRPN

ACTIVE COMPARATOR

Subjects assigned to group B will receive surgical treatment of robotic partial nephrectomy (RPN), through temporary closure of the renal hilar vessels and renorrhaphy (RR), i.e. by juxtaposing the resection margins of the enucleation bed

Procedure: Robotic partial nephrectomy

Interventions

Robotic partial nephrectomy PROCEDURE

Robotic partial nephrectomy (RPN) is the treatment of choice for organ-confined renal tumors. For to improve functional outcomes, we designed an off-clamp and suture-free approach (SL) to limit the ischemic damage and destruction of the renal parenchyma caused, respectively, by temporary closure of the vessels of the renal hilum and by renorrhaphy (RR) (i.e. by the juxtaposition of the margins of resection of the enucleation bed, which is commonly performed at the end of tumor exeresis using suture threads stopped by surgical clips)

RR-ocRPN; SL-ocRPN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• radiological diagnosis of organ-confined renal neoplasm (cT1-2 cN0);
• patient who is a candidate, due to personal or tumor characteristics, for ocRPN intervention;
• compliant patient, able to follow the procedures/follow-up;
• patient who agrees to participate in the clinical study and the planned randomization, by signing the informed consent.

You may not qualify if:

• preoperative evidence of unilateral/bilateral synchronous renal neoplasms;
• personal history of renal surgery for benign or malignant pathology.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, Rome, 00144, Italy

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Aldo Brassetti, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized trial on surgical techniques used in clinical practice, relating to patients with organ-confined renal tumors who are candidates for OCRPN surgery, designed with the aim of prospectively demonstrating that SL-ocRPN is not inferior to RR-ocRPN in terms of surgical results (expressed by the Trifecta rate)

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: February 25, 2025
• Study Start: July 7, 2023
• Primary Completion (Estimated): July 7, 2028
• Study Completion (Estimated): July 7, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)