Actively Recruiting

Phase Not Applicable
Age: 15Years - 80Years
All Genders
ID06715878

Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial

Led by RenJi Hospital · Updated on 2024-12-10

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new surgical technique called zero ischemia robot-assisted microwave ablation assisted suture-less tumor enucleation for patients with T1 stage renal cell carcinoma (RCC). This study builds on previous findings where the laparoscopic version of this technique showed better preservation of kidney function compared to conventional laparoscopic partial nephrectomy. The goal is to adapt this approach to robotic surgery, adding suture-less methods and using real-time contrast-enhanced ultrasonography to improve safety and precision. The study compares two groups of patients with T1 stage RCC: one group undergoes the zero ischemia robot-assisted microwave ablation and suture-less tumor enucleation, while the other group has traditional robotic-assisted partial nephrectomy. During the experimental procedure, a microwave ablation probe is inserted into the tumor under ultrasound guidance, with controlled ablation cycles to minimize bleeding. The tumor is then carefully separated from the kidney without clamping the renal artery, and suturing is done only if needed to repair the urinary collecting system. Participants will be followed for at least 12 months after surgery with various assessments including measurements of kidney function through glomerular filtration rate (GFR) and estimated GFR (eGFR), blood loss during surgery, surgical margins, postoperative complications, recurrence rates, and hospital stay duration. The study includes baseline, 3-month, and 12-month evaluations to monitor kidney function and other outcomes. This monitoring aims to understand the impact of the new surgical technique on kidney preservation and patient recovery.

CONDITIONS

Brief Title

Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage

Who Can Participate

Age: 15Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
  • Patients scheduled for robot-assisted laparoscopic nephron sparing surgery
  • Patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
  • Patients agreeable to participate in this long-term follow-up study
Not Eligible

You will not qualify if you...

  • Patients older than 80 years
  • Patients with other renal diseases (including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
  • Patients not able to tolerate the robot-assisted laparoscopic procedure
  • Patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
  • Patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks or until discharge

Participants undergo either Zero Ischemia Robot-Assisted Microwave Ablation assisted suture-less tumor enucleation or traditional robotic-assisted partial nephrectomy, followed by immediate post-operative care to monitor surgical outcomes and complications.

1 surgical visit and approximately 6 post-operative visits

Post-operative Follow-up

Duration - 12 months

Participants are monitored for renal function, surgical margins, complications, and cancer progression or recurrence over the year following surgery.

Visits at baseline, 3 months, and 12 months

Trial Site Locations

Total: 1 location

1

Ethics Committee of Shanghai Renji Hospital

Shanghai, China

Actively Recruiting

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Research Team

J

Jiwei Huang, PhD.

Y

Yiran Huang, MD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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