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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Kidney Neoplasms

Treatments: Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE); Procedure: conventional laparoscopic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02734329

RenJiH-2016006

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Zero Ischemia group

Experimental group

Description:

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.

Treatment:

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

Conventional group

Active Comparator group

Description:

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

Treatment:

Procedure: conventional laparoscopic partial nephrectomy