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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Renal Cell Carcinoma

Treatments: Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE; Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02924597

RenJiH-20160829

Details and patient eligibility

About

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.

Enrollment: 100 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Robot-assisted 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 robot-assisted laparoscopic RFA assisted TE

Robot-Assisted laparoscopic partial nephrectomy

Active Comparator group

Description:

The tumor then will be laparoscopic enucleation without hilar clamping.

Treatment:

Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy