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

NCT ID: NCT02734329

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zero Ischemia group

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Conventional group

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

Group Type ACTIVE_COMPARATOR

conventional laparoscopic partial nephrectomy

Intervention Type PROCEDURE

renal artery will be clamped during surgery.

Interventions

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conventional laparoscopic partial nephrectomy

renal artery will be clamped during surgery.

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yiran Huang

Director of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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jiwei huang, M.D.

Role: CONTACT

862168383776

Facility Contacts

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jiwei huang, M.D

Role: primary

86-21-68383716

Other Identifiers

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RenJiH-2016006

Identifier Type: -

Identifier Source: org_study_id

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