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Trial record 42 of 6058 for:    zero

Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02326558
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Huang Yi-Ran, RenJi Hospital

Tracking Information
First Submitted Date  ICMJE December 17, 2014
First Posted Date  ICMJE December 29, 2014
Last Update Posted Date April 5, 2017
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
absolute change in glomerular filtration rate (GFR) of the affected kidney [ Time Frame: baseline, 3 months and 12 months ]
measured by renal scintigraphy
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
absolute change in glomerular filtration rate (GFR) of the affected kidney [ Time Frame: baseline and 6 months ]
measured by renal scintigraphy
Change History Complete list of historical versions of study NCT02326558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • absolute change in eGFR of the affected kidney [ Time Frame: baseline, 3 months, 6 months and 12 months ]
  • absolute change in total GFR [ Time Frame: baseline and 6 months ]
    measured by renal scintigraphy
  • blood loss [ Time Frame: during surgery ]
  • operation time [ Time Frame: during surgery ]
  • surgical margin [ Time Frame: 1 month ]
    assessed according to the pathology report of the operation specimen
  • postoperative complications [ Time Frame: up to 6 months ]
    number of participants with postoperative complications graded by Clavien- Dindo system
  • progression-free survival [ Time Frame: 12 months ]
  • local recurrence [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
  • absolute change in eGFR of the affected kidney [ Time Frame: baseline, 1 month and 6 months ]
  • absolute change in total GFR [ Time Frame: baseline and 6 months ]
    measured by renal scintigraphy
  • blood loss [ Time Frame: during surgery ]
  • operation time [ Time Frame: during surgery ]
  • surgical margin [ Time Frame: 1 month ]
    assessed according to the pathology report of the operation specimen
  • postoperative complications [ Time Frame: up to 6 months ]
    number of participants with postoperative complications graded by Clavien- Dindo system
  • progression-free survival [ Time Frame: 12 months, 3 years and 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
Official Title  ICMJE Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
Brief Summary The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
Detailed Description Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Procedure: laparoscopic microwave ablation-assisted enucleation
  • Procedure: conventional laparoscopic partial nephrectomy
Study Arms  ICMJE
  • Experimental: microwave enucleation
    zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor
    Intervention: Procedure: laparoscopic microwave ablation-assisted enucleation
  • Active Comparator: laparoscopic partial nephrectomy
    conventional laparoscopic partial nephrectomy with clamping of the renal artery
    Intervention: Procedure: conventional laparoscopic partial nephrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2017)
183
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2014)
90
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
  • exophytic cancer
  • distance from the hilar renal vessels and urinary collecting system >= 1cm
  • patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
  • patients giving consent to the participation in the current clinical trial

Exclusion Criteria:

  • patients with a history of other renal diseases, such as urinary lithiasis
  • patients with a history of renal surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326558
Other Study ID Numbers  ICMJE RenJiH-URO-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Huang Yi-Ran, RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE National Natural Science Foundation of China
Investigators  ICMJE
Study Chair: Yi-Ran Huang, M.D. RenJi Hospital
PRS Account RenJi Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP