Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

October 3, 2016 updated by: RenJi Hospital

Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial

To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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 Locations

  • China
    • Shanghai
      • Shanghai, 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

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with sporadic, unilateral, newly diagnosed T1a 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

Exclusion Criteria:

  • patients' aged >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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted laparoscopic RFA assisted TE
RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping.
Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE
Other Names:
  • zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation
Active Comparator: Robot-Assisted laparoscopic partial nephrectomy
The tumor then will be laparoscopic enucleation without hilar clamping.
Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy
Other Names:
  • Off-clamp robot-assisted partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The changes of estimated GFR (eGFR)
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
postoperative complications
Time Frame: postoperative，up to 30 days
postoperative，up to 30 days
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
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time Frame: baseline and 6 months
baseline and 6 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

January 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-20160829

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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