Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

Shanghai Jiao Tong University

Status: Unknown

Conditions: Renal Cell Carcinoma; Zero Ischemia

Treatments: Procedure: ischemia; Procedure: zero ischemia laparoscopic RFA assisted TE

Study type: Interventional

Funder types: Other

Identifiers

NCT01838720

RenJiH-20130406

Details and patient eligibility

About

To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.

Full description

Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

Enrollment: 90 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
• 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
• 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 close to the calyces

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

zero ischemia laparoscopic RFA assisted TE

Experimental group

Description:

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.

Treatment:

Procedure: zero ischemia laparoscopic RFA assisted TE

conventional laparoscopic partial nephrectomy

Active Comparator group

Description:

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

Treatment:

Procedure: ischemia