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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Yiran Huang, RenJi Hospital.
Recruitment status was:  Recruiting
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
Intervention Model: Single Group Assignment
Masking: None (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 Yiran Huang, RenJi Hospital:

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


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

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

  • estimated GFR (eGFR) of 6 month [ Time Frame: 6 month ]
  • changes in GFR of total kidneys by renal scintigraphyby of 6 month [ Time Frame: 6 month ]

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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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

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

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

ClinicalTrials.gov processed this record on September 21, 2017