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Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

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ClinicalTrials.gov Identifier: NCT02924597
Recruitment Status : Unknown
Verified October 2016 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Procedure: zero ischemia robot-assisted laparoscopic RFA assisted TE Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot-assisted 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 robot-assisted laparoscopic RFA assisted TE
Other Name: zero ischemia robot-assisted laparoscopic radio frequency ablation assisted tumor enucleation

Active Comparator: Robot-Assisted laparoscopic partial nephrectomy
The tumor then will be laparoscopic enucleation without hilar clamping.
Procedure: zero ischemia robot-assisted laparoscopic partial nephrectomy
Other Name: Off-clamp robot-assisted partial nephrectomy




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

  2. The changes of estimated GFR (eGFR) [ Time Frame: baseline and 12 months ]
    12 months minus baseline


Secondary Outcome Measures :
  1. estimated blood loss [ Time Frame: during surgery ]
  2. changes in GFR of total kidneys by renal scintigraphyby [ Time Frame: baseline and 12 months ]
  3. surgical margin [ Time Frame: postoperative,up to 2 weeks after surgery ]
  4. postoperative complications [ Time Frame: postoperative,up to 30 days ]
  5. progression-free survival [ Time Frame: 12 months ]
  6. local recurrence [ Time Frame: 12 months ]
  7. operative time [ Time Frame: During surgery ]
  8. Hospital stay time [ Time Frame: The time from the surgery day to patient discharge, up to 2 weeks ]
  9. changes in GFR of total kidneys by renal scintigraphyby of 6 month [ Time Frame: baseline and 6 months ]


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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
  • patients scheduled for robot-assisted laparoscopic nephron sparing surgery
  • 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,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
  • patients not able to tolerate the robot-assisted laparoscopic procedure
  • patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
  • patients with the renal tumor involving urinary collecting system

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): NCT02924597


Contacts
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Contact: Jin Zhang, PhD. +8618801967501 rjxuyunze@163.com
Contact: Yiran Huang, MD. +8613501835219 huangyrrenji@163.com

Locations
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China, Shanghai
Ethics Committee of Shanghai Renji Hospital Recruiting
Shanghai, Shanghai, China
Contact: Qi Lu    +86021-68383364    rjllb3364@163.com   
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02924597     History of Changes
Other Study ID Numbers: RenJiH-20160829
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases