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

Renal Cell Carcinoma Clinical Trial

Official title:

Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02924597
• Other study ID #: RenJiH-20160829
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2016
• Last updated: October 3, 2016
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2016
• Source: RenJi Hospital
• Contact: Jin Zhang, PhD.
• Phone: +8618801967501
• Email: rjxuyunze[@]163.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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 (di?erential 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 in?ammatory conditions of the operative kidney

• patients with the renal tumor involving urinary collecting system

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• zero ischemia robot-assisted laparoscopic RFA assisted TE

• zero ischemia robot-assisted laparoscopic partial nephrectomy

Locations

Country	Name	City	State
China	Ethics Committee of Shanghai Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute change in glomerular ?ltration rate (GFR) of the a?ected kidney	12 months minus baseline	baseline and 12 months	Yes
Primary	The changes of estimated GFR (eGFR)	12 months minus baseline	baseline and 12 months	Yes
Secondary	estimated blood loss		during surgery	Yes
Secondary	changes in GFR of total kidneys by renal scintigraphyby		baseline and 12 months	Yes
Secondary	surgical margin		postoperative,up to 2 weeks after surgery	Yes
Secondary	postoperative complications		postoperative,up to 30 days	Yes
Secondary	progression-free survival		12 months	Yes
Secondary	local recurrence		12 months	Yes
Secondary	operative time		During surgery	Yes
Secondary	Hospital stay time		The time from the surgery day to patient discharge, up to 2 weeks	Yes
Secondary	changes in GFR of total kidneys by renal scintigraphyby of 6 month		baseline and 6 months	Yes