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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

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ClinicalTrials.gov Identifier: NCT01838720
Recruitment Status : Unknown
Verified August 2014 by Yiran Huang, RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : April 24, 2013
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Yiran Huang, RenJi Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Zero Ischemia Procedure: zero ischemia laparoscopic RFA assisted TE Procedure: ischemia Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Study Start Date : April 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

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U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. estimated GFR (eGFR) [ Time Frame: 12 months ]
  2. changes in GFR of total kidneys by renal scintigraphyby [ Time Frame: baseline and 12 months ]
  3. blood loss [ Time Frame: during surgery ]
  4. surgical margin [ Time Frame: postoperative ]
    pathologic confirm of surgical margin

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

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yiran Huang, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier: NCT01838720     History of Changes
Other Study ID Numbers: RenJiH-20130406
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 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