NCT02326558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

December 17, 2014

Last Update Submit

April 3, 2017

Conditions

Renal Cell Carcinoma

Keywords

zero ischemiamicrowaveablationenucleationrenal cell carcinoma

Outcome Measures

Primary Outcomes (1)

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

    measured by renal scintigraphy

    baseline, 3 months and 12 months

Secondary Outcomes (8)

  • absolute change in eGFR of the affected kidney

    baseline, 3 months, 6 months and 12 months

  • absolute change in total GFR

    baseline and 6 months

  • blood loss

    during surgery

  • operation time

    during surgery

  • surgical margin

    1 month

  • +3 more secondary outcomes

Study Arms (2)

microwave enucleation

EXPERIMENTAL

zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor

Procedure: laparoscopic microwave ablation-assisted enucleation

laparoscopic partial nephrectomy

ACTIVE COMPARATOR

conventional laparoscopic partial nephrectomy with clamping of the renal artery

Procedure: conventional laparoscopic partial nephrectomy

Interventions

laparoscopic microwave ablation-assisted enucleationPROCEDURE
microwave enucleation
conventional laparoscopic partial nephrectomyPROCEDURE
laparoscopic partial nephrectomy

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Yi-Ran Huang, M.D.

    RenJi Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef of Urology

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 29, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

September 1, 2016

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

CN(1)