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

Primary Purpose

Renal Cell Carcinoma

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

About this trial

This is an interventional prevention trial for Renal Cell Carcinoma

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 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

Sites / Locations

  • Ethics Committee of Shanghai Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot-assisted laparoscopic RFA assisted TE

Robot-Assisted 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.

The tumor then will be laparoscopic enucleation without hilar clamping.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

estimated blood loss
changes in GFR of total kidneys by renal scintigraphyby
surgical margin
postoperative complications
progression-free survival
local recurrence
operative time
Hospital stay time
changes in GFR of total kidneys by renal scintigraphyby of 6 month

Full Information

First Posted
October 3, 2016
Last Updated
October 3, 2016
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02924597
Brief Title
Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage
Official Title
Robot-Assisted 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
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted 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
Robot-Assisted laparoscopic partial nephrectomy
Arm Type
Active Comparator
Arm Description
The tumor then will be laparoscopic enucleation without hilar clamping.
Intervention Type
Procedure
Intervention Name(s)
zero ischemia robot-assisted laparoscopic RFA assisted TE
Other Intervention Name(s)
zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation
Intervention Type
Procedure
Intervention Name(s)
zero ischemia robot-assisted laparoscopic partial nephrectomy
Other Intervention Name(s)
Off-clamp robot-assisted 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
Title
The changes of estimated GFR (eGFR)
Description
12 months minus baseline
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
estimated blood loss
Time Frame
during surgery
Title
changes in GFR of total kidneys by renal scintigraphyby
Time Frame
baseline and 12 months
Title
surgical margin
Time Frame
postoperative，up to 2 weeks after surgery
Title
postoperative complications
Time Frame
postoperative，up to 30 days
Title
progression-free survival
Time Frame
12 months
Title
local recurrence
Time Frame
12 months
Title
operative time
Time Frame
During surgery
Title
Hospital stay time
Time Frame
The time from the surgery day to patient discharge, up to 2 weeks
Title
changes in GFR of total kidneys by renal scintigraphyby of 6 month
Time Frame
baseline and 6 months

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Zhang, PhD.
Phone
+8618801967501
Email
rjxuyunze@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiran Huang, MD.
Phone
+8613501835219
Email
huangyrrenji@163.com
Facility Information:
Facility Name
Ethics Committee of Shanghai Renji Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Lu
Phone
+86021-68383364
Email
rjllb3364@163.com

12. IPD Sharing Statement

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

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