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

Primary Purpose

Kidney Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional laparoscopic partial nephrectomy
zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Neoplasms focused on measuring Nephron sparing surgery, Zero ischemia, Warm ischemia, Laparoscopic, Radiofrequency ablation, Microwave 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 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

Sites / Locations

  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero Ischemia group

Conventional group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

the change in glomerular filtration rate (GFR) of the affected kidney
changes of estimated GFR (eGFR)

Secondary Outcome Measures

estimated blood loss
rates of positive surgical margin
postoperative complications
the rate of local recurrence
operative time
Hospital stay time
progression-free survival rate

Full Information

First Posted
February 29, 2016
Last Updated
May 1, 2016
Sponsor
RenJi Hospital
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital, Changhai Hospital, Shanghai 6th People's Hospital, Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02734329
Brief Title
Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Changzheng Hospital, Changhai Hospital, Shanghai 6th People's Hospital, Fudan University

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms
Keywords
Nephron sparing surgery, Zero ischemia, Warm ischemia, Laparoscopic, Radiofrequency ablation, Microwave ablation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Zero Ischemia group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional group
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)
conventional laparoscopic partial nephrectomy
Intervention Description
renal artery will be clamped during surgery.
Intervention Type
Procedure
Intervention Name(s)
zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
Primary Outcome Measure Information:
Title
the change in glomerular filtration rate (GFR) of the affected kidney
Time Frame
Baseline and 30 months
Title
changes of estimated GFR (eGFR)
Time Frame
Baseline and 30 months
Secondary Outcome Measure Information:
Title
estimated blood loss
Time Frame
during surgery
Title
rates of positive surgical margin
Time Frame
postoperative，up to 2 weeks after surgery
Title
postoperative complications
Time Frame
postoperative，up to 30 days
Title
the rate of local recurrence
Time Frame
through study completion, an average of 3 years
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
progression-free survival rate
Time Frame
through study completion, an average of 3 years

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jiwei huang, M.D.
Phone
862168383776
Email
jiweihuang@outlook.com
Facility Information:
Facility Name
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiwei huang, M.D
Phone
86-21-68383716
Email
jiweihuang@outlook.com
First Name & Middle Initial & Last Name & Degree
Yiran Huang, M.D

12. IPD Sharing Statement

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

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