Trial record 1 of 1 for:    NCT01838720
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Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by RenJi Hospital
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Yiran Huang, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01838720
First received: April 14, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Renal Cell Carcinoma
Zero Ischemia
Procedure: zero ischemia laparoscopic RFA assisted TE
Procedure: ischemia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • the absolute change in glomerular filtration rate (GFR) of the affected kidney [ Time Frame: baseline and 12 months ] [ Designated as safety issue: Yes ]
    12 months minus baseline


Secondary Outcome Measures:
  • estimated GFR (eGFR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • changes in GFR of total kidneys by renal scintigraphyby [ Time Frame: baseline and 12 months ] [ Designated as safety issue: Yes ]
  • blood loss [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
  • surgical margin [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]
    pathologic confirm of surgical margin

  • postoperative complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • local recurrence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the absolute change in glomerular filtration rate (GFR) of the affected kidney [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
    6 months minus baseline

  • estimated GFR (eGFR) of 6 month [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • changes in GFR of total kidneys by renal scintigraphyby of 6 month [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zero ischemia laparoscopic RFA assisted TE
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.
Procedure: zero ischemia laparoscopic RFA assisted TE
Other Name: zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation
Active Comparator: conventional laparoscopic partial nephrectomy
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Procedure: ischemia
conventional laparoscopic partial nephrectomy
Other Name: renal artery will be clamped during surgery.

Detailed 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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838720

Contacts
Contact: Yiran Huang, M.D. 86-13501835219 yrhuangrenji@163.com

Locations
China, Shanghai
RenJi Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Yiran Huang, M.D.    86-13501835219    yrhuangrenji@163.com   
Principal Investigator: Yiran Huang, M.D.         
Sponsors and Collaborators
RenJi Hospital
National Natural Science Foundation of China
Investigators
Principal Investigator: Yiran Huang, M.D. RenJi Hospital
  More Information

No publications provided

Responsible Party: Yiran Huang, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier: NCT01838720     History of Changes
Other Study ID Numbers: RenJiH-20130406
Study First Received: April 14, 2013
Last Updated: August 12, 2014
Health Authority: China: Ethics Committee

Keywords provided by RenJi Hospital:
renal cell carcinoma
ischemia
radio frequency ablation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Ischemia
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014