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


N/A
15 Years
80 Years
Open (Enrolling)
Both
Renal Cell Carcinoma, Zero Ischemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the absolute change in glomerular filtration rate (GFR) of the affected kidney

Outcome Description:

6 months minus baseline

Outcome Time Frame:

baseline and 6 months

Safety Issue:

Yes

Principal Investigator

Yiran Huang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

RenJi Hospital

Authority:

China: Ethics Committee

Study ID:

RenJiH-20130406

NCT ID:

NCT01838720

Start Date:

April 2013

Completion Date:

October 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Zero Ischemia
  • renal cell carcinoma
  • ischemia
  • radio frequency ablation
  • Carcinoma
  • Carcinoma, Renal Cell
  • Ischemia

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