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

Primary Purpose

Renal Cell Carcinoma, Zero Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
zero ischemia laparoscopic RFA assisted TE
ischemia
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring renal cell carcinoma, ischemia, radio frequency ablation

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RenJi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

zero ischemia laparoscopic RFA assisted TE

conventional laparoscopic partial nephrectomy

Arm Description

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.

Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.

Outcomes

Primary Outcome Measures

the absolute change in glomerular filtration rate (GFR) of the affected kidney
12 months minus baseline

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2013
Last Updated
August 12, 2014
Sponsor
RenJi Hospital
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01838720
Brief Title
Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
Official Title
Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Zero Ischemia
Keywords
renal cell carcinoma, ischemia, radio frequency ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
zero ischemia laparoscopic RFA assisted TE
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional laparoscopic partial nephrectomy
Arm Type
Active Comparator
Arm Description
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Intervention Type
Procedure
Intervention Name(s)
zero ischemia laparoscopic RFA assisted TE
Other Intervention Name(s)
zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation
Intervention Type
Procedure
Intervention Name(s)
ischemia
Other Intervention Name(s)
renal artery will be clamped during surgery.
Intervention Description
conventional laparoscopic partial nephrectomy
Primary Outcome Measure Information:
Title
the absolute change in glomerular filtration rate (GFR) of the affected kidney
Description
12 months minus baseline
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
estimated GFR (eGFR)
Time Frame
12 months
Title
changes in GFR of total kidneys by renal scintigraphyby
Time Frame
baseline and 12 months
Title
blood loss
Time Frame
during surgery
Title
surgical margin
Description
pathologic confirm of surgical margin
Time Frame
postoperative
Title
postoperative complications
Time Frame
12 months
Title
progression-free survival
Time Frame
12 months
Title
local recurrence
Time Frame
12 months
Title
the absolute change in glomerular filtration rate (GFR) of the affected kidney
Description
6 months minus baseline
Time Frame
baseline and 6 months
Title
estimated GFR (eGFR) of 6 month
Time Frame
6 month
Title
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiran Huang, M.D.
Phone
86-13501835219
Email
yrhuangrenji@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiran Huang, M.D.
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
RenJi Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiran Huang, M.D.
Phone
86-13501835219
Email
yrhuangrenji@163.com
First Name & Middle Initial & Last Name & Degree
Yiran Huang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
26905020
Citation
Huang J, Zhang J, Wang Y, Kong W, Xue W, Liu D, Chen Y, Huang Y. Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor: A Randomized Clinical Trial. J Urol. 2016 Jun;195(6):1677-83. doi: 10.1016/j.juro.2015.12.115. Epub 2016 Feb 22.
Results Reference
derived

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

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