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Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

laparoscopic microwave ablation-assisted enucleation

conventional laparoscopic partial nephrectomy

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring zero ischemia, microwave, ablation, enucleation, 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
exophytic cancer
distance from the hilar renal vessels and urinary collecting system >= 1cm
patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
patients giving consent to the participation in the current clinical trial

Exclusion Criteria:

patients with a history of other renal diseases, such as urinary lithiasis
patients with a history of renal surgery

Sites / Locations

Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

microwave enucleation

laparoscopic partial nephrectomy

Arm Description

zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor

conventional laparoscopic partial nephrectomy with clamping of the renal artery

Outcomes

Primary Outcome Measures

absolute change in glomerular filtration rate (GFR) of the affected kidney

measured by renal scintigraphy

Secondary Outcome Measures

absolute change in eGFR of the affected kidney

absolute change in total GFR

measured by renal scintigraphy

blood loss

operation time

surgical margin

assessed according to the pathology report of the operation specimen

postoperative complications

number of participants with postoperative complications graded by Clavien- Dindo system

progression-free survival

local recurrence

Full Information

NCT ID

NCT02326558

First Posted

December 17, 2014

Last Updated

April 3, 2017

Sponsor

RenJi Hospital

Collaborators

National Natural Science Foundation of China

1. Study Identification

Unique Protocol Identification Number

NCT02326558

Brief Title

Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Official Title

Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

September 2016 (Actual)

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

The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.

Detailed Description

Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with 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

Keywords

zero ischemia, microwave, ablation, enucleation, renal cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

microwave enucleation

Arm Type

Experimental

Arm Description

zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor

Arm Title

laparoscopic partial nephrectomy

Arm Type

Active Comparator

Arm Description

conventional laparoscopic partial nephrectomy with clamping of the renal artery

Intervention Type

Procedure

Intervention Name(s)

laparoscopic microwave ablation-assisted enucleation

Intervention Type

Procedure

Intervention Name(s)

conventional laparoscopic partial nephrectomy

Primary Outcome Measure Information:

Title

absolute change in glomerular filtration rate (GFR) of the affected kidney

Description

measured by renal scintigraphy

Time Frame

baseline, 3 months and 12 months

Secondary Outcome Measure Information:

Title

absolute change in eGFR of the affected kidney

Time Frame

baseline, 3 months, 6 months and 12 months

Title

absolute change in total GFR

Description

measured by renal scintigraphy

Time Frame

baseline and 6 months

Title

blood loss

Time Frame

during surgery

Title

operation time

Time Frame

during surgery

Title

surgical margin

Description

assessed according to the pathology report of the operation specimen

Time Frame

1 month

Title

postoperative complications

Description

number of participants with postoperative complications graded by Clavien- Dindo system

Time Frame

up to 6 months

Title

progression-free survival

Time Frame

12 months

Title

local recurrence

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma exophytic cancer distance from the hilar renal vessels and urinary collecting system >= 1cm patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy) patients giving consent to the participation in the current clinical trial Exclusion Criteria: patients with a history of other renal diseases, such as urinary lithiasis patients with a history of renal surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi-Ran Huang, M.D.

Organizational Affiliation

RenJi Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Renji Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

12. IPD Sharing Statement

Learn more about this trial

Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

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