Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

NCT ID: NCT02924597

Last Updated: 2016-10-05

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

Brief Summary

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To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Robot-assisted laparoscopic RFA assisted TE

RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping.

Group Type EXPERIMENTAL

zero ischemia robot-assisted laparoscopic RFA assisted TE

Intervention Type PROCEDURE

Robot-Assisted laparoscopic partial nephrectomy

The tumor then will be laparoscopic enucleation without hilar clamping.

Group Type ACTIVE_COMPARATOR

zero ischemia robot-assisted laparoscopic partial nephrectomy

Intervention Type PROCEDURE

Interventions

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zero ischemia robot-assisted laparoscopic RFA assisted TE

Intervention Type PROCEDURE

zero ischemia robot-assisted laparoscopic partial nephrectomy

Intervention Type PROCEDURE

Other Intervention Names

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zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation Off-clamp robot-assisted partial nephrectomy

Eligibility Criteria

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Inclusion Criteria

* patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
* patients scheduled for robot-assisted laparoscopic nephron sparing surgery
* patients with normal contralateral renal function (differential renal function of \>40% as determined by radionuclide scintigraphy)
* 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 robot-assisted 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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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ethics Committee of Shanghai Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin Zhang, PhD.

Role: CONTACT

+8618801967501

Yiran Huang, MD.

Role: CONTACT

+8613501835219

Facility Contacts

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Qi Lu

Role: primary

+86021-68383364

Other Identifiers

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RenJiH-20160829

Identifier Type: -

Identifier Source: org_study_id

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