NCT02734329

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

4.4 years

First QC Date

February 29, 2016

Last Update Submit

May 1, 2016

Conditions

Kidney Neoplasms

Keywords

Nephron sparing surgeryZero ischemiaWarm ischemiaLaparoscopicRadiofrequency ablationMicrowave ablation

Outcome Measures

Primary Outcomes (2)

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

    Baseline and 30 months

  • changes of estimated GFR (eGFR)

    Baseline and 30 months

Secondary Outcomes (7)

  • estimated blood loss

    during surgery

  • rates of positive surgical margin

    postoperative，up to 2 weeks after surgery

  • postoperative complications

    postoperative，up to 30 days

  • the rate of local recurrence

    through study completion, an average of 3 years

  • operative time

    During surgery

  • +2 more secondary outcomes

Study Arms (2)

Zero Ischemia group

EXPERIMENTAL

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.

Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)

Conventional group

ACTIVE COMPARATOR

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

Procedure: conventional laparoscopic partial nephrectomy

Interventions

conventional laparoscopic partial nephrectomyPROCEDURE

renal artery will be clamped during surgery.

Conventional group
zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)PROCEDURE
Zero Ischemia group

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 T1 presumed renal cell carcinoma
  • patients scheduled for laparoscopic nephron sparing surgery
  • patients agreeable to participate in this long-term follow-up study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

jiwei huang, M.D.

CONTACT

862168383776jiweihuang@outlook.com

Study Design

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

Study Record Dates

First Submitted

February 29, 2016

First Posted

April 12, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2020

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

CN(1)