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

December 8, 2024 updated by: RenJi Hospital

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

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ethics Committee of Shanghai Renji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
  2. patients scheduled for robot-assisted laparoscopic nephron sparing surgery
  3. patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
  4. patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zero Ischemia suture-less group
Patients with T1 Stage renal cell carcinoma undergoing Zero Ischemia, Robot-Assisted Microwave Ablation assisted suture-less tumor Enucleation.
Procedure: Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation
Under the visualization of ultrasound contrast imaging through the operative channel, a microwave ablation probe was inserted into the tumor (at the interface between the tumor and kidney, close to the tumor base). The microwave ablation device was used, with a power setting of 70 W for initiating microwave ablation. Depending on the tumor volume and depth, 1-3 ablation cycles were performed, with each cycle lasting 1-3 minutes. After reaching the pseudocapsule of the tumor, a combination of blunt dissection, sharp cutting, and blunt dissection was employed to separate the tumor from the renal parenchyma . The renal artery was not occluded during the procedure.If intraoperative injury to the collecting system is suspected, the collecting system should be sutured normally, while simultaneously suturing the outer layer of renal parenchyma to prevent urine leakage.
Active Comparator: robotic-assisted partial nephrectomy group
Patients with T1 stage Renal Cell Carcinoma undergoing traditional robotic-assisted partial nephrectomy.
Procedure: robotic-assisted laparoscopic partial nephrectomy
robotic-assisted laparoscopic partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of estimated GFR (eGFR)
Time Frame: baseline and 12 months
12 months minus baseline
baseline and 12 months
The absolute change in glomerular filtration rate (GFR) of the affected kidney
Time Frame: baseline and 12 months
12 months minus baseline
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 12 months
12 months
changes in GFR of total kidneys by renal scintigraphyby
Time Frame: baseline and 12 months
baseline and 12 months
local recurrence
Time Frame: 12 months
12 months
estimated blood loss
Time Frame: during surgery
during surgery
operative time
Time Frame: During surgery
During surgery
Hospital stay time
Time Frame: The time from the surgery day to patient discharge, up to 2 weeks
The time from the surgery day to patient discharge, up to 2 weeks
surgical margin
Time Frame: postoperative up to 2 weeks after surgery
postoperative up to 2 weeks after surgery
postoperative complications
Time Frame: postoperative up to 30 days
postoperative up to 30 days
changes in GFR of total kidneys by renal scintigraphyby of 3 month
Time Frame: baseline and 3 months
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRACLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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