Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

August 12, 2014 updated by: Yiran Huang, RenJi Hospital

Zero Ischemia 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 laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

Study Type

Interventional

Enrollment (Anticipated)

90

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, 200127
        • Recruiting
        • Renji hospital
        • Contact:
        • Principal Investigator:
          • Yiran Huang, M.D.

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 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
  • patients not able to tolerate the laparoscopic procedure
  • patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
  • patients with the renal tumor close to the calyces

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zero ischemia 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 laparoscopic RFA assisted TE
Other Names:
  • zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation
Active Comparator: conventional laparoscopic partial nephrectomy
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Procedure: ischemia
conventional laparoscopic partial nephrectomy
Other Names:
  • renal artery will be clamped during surgery.

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 12 months
12 months
estimated GFR (eGFR)
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
blood loss
Time Frame: during surgery
during surgery
surgical margin
Time Frame: postoperative
pathologic confirm of surgical margin
postoperative
postoperative complications
Time Frame: 12 months
12 months
local recurrence
Time Frame: 12 months
12 months
the absolute change in glomerular filtration rate (GFR) of the affected kidney
Time Frame: baseline and 6 months
6 months minus baseline
baseline and 6 months
estimated GFR (eGFR) of 6 month
Time Frame: 6 month
6 month
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Collaborators

National Natural Science Foundation of China

Investigators

  • Principal Investigator: Yiran Huang, M.D., Renji hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

April 14, 2013

First Submitted That Met QC Criteria

April 20, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-20130406

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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