Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage

May 1, 2016 updated by: Yiran Huang, RenJi Hospital
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 T1 RCC patients in randomized clinical trial in multiple centers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

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, China, 200127
        • Recruiting
        • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
        • 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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
  • patients scheduled for laparoscopic nephron sparing surgery
  • 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 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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zero Ischemia group
Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases.
Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
ACTIVE_COMPARATOR: Conventional group
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Procedure: conventional laparoscopic partial nephrectomy
renal artery will be clamped during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the change in glomerular filtration rate (GFR) of the affected kidney
Time Frame: Baseline and 30 months
Baseline and 30 months
changes of estimated GFR (eGFR)
Time Frame: Baseline and 30 months
Baseline and 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
estimated blood loss
Time Frame: during surgery
during surgery
postoperative complications
Time Frame: postoperative，up to 30 days
postoperative，up to 30 days
rates of positive surgical margin
Time Frame: postoperative，up to 2 weeks after surgery
postoperative，up to 2 weeks after surgery
the rate of local recurrence
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years
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
progression-free survival rate
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Collaborators

Changhai Hospital
Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Shanghai 6th People's 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

April 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 12, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-2016006

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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