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

Renal Cell Carcinoma Clinical Trial

Official title:

Zero Ischemia 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: NCT01838720
• Other study ID #: RenJiH-20130406
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2013
• Last updated: August 12, 2014
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: RenJi Hospital
• Contact: Yiran Huang, M.D.
• Phone: 86-13501835219
• Email: yrhuangrenji[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• 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 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

• patients not able to tolerate the laparoscopic procedure

• patients with previous renal surgery or history of any in?ammatory conditions of the operative kidney

• patients with the renal tumor close to the calyces

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Ischemia
• Renal Cell Carcinoma
• Zero Ischemia

Intervention

Procedure:
• zero ischemia laparoscopic RFA assisted TE

• ischemia
conventional laparoscopic partial nephrectomy

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	National Natural Science Foundation of China

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
Secondary	estimated GFR (eGFR)		12 months	Yes
Secondary	changes in GFR of total kidneys by renal scintigraphyby		baseline and 12 months	Yes
Secondary	blood loss		during surgery	Yes
Secondary	surgical margin	pathologic confirm of surgical margin	postoperative	Yes
Secondary	postoperative complications		12 months	Yes
Secondary	progression-free survival		12 months	Yes
Secondary	local recurrence		12 months	Yes
Secondary	the absolute change in glomerular ?ltration rate (GFR) of the a?ected kidney	6 months minus baseline	baseline and 6 months	Yes
Secondary	estimated GFR (eGFR) of 6 month		6 month	Yes
Secondary	changes in GFR of total kidneys by renal scintigraphyby of 6 month		6 month	No