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Trial record 42 of 5997 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

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Procedure: laparoscopic microwave ablation-assisted enucleation Procedure: conventional laparoscopic partial nephrectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
Actual Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: microwave enucleation
zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor
Procedure: laparoscopic microwave ablation-assisted enucleation
Active Comparator: laparoscopic partial nephrectomy
conventional laparoscopic partial nephrectomy with clamping of the renal artery
Procedure: conventional laparoscopic partial nephrectomy



Primary Outcome Measures :
  1. absolute change in glomerular filtration rate (GFR) of the affected kidney [ Time Frame: baseline, 3 months and 12 months ]
    measured by renal scintigraphy


Secondary Outcome Measures :
  1. absolute change in eGFR of the affected kidney [ Time Frame: baseline, 3 months, 6 months and 12 months ]
  2. absolute change in total GFR [ Time Frame: baseline and 6 months ]
    measured by renal scintigraphy

  3. blood loss [ Time Frame: during surgery ]
  4. operation time [ Time Frame: during surgery ]
  5. surgical margin [ Time Frame: 1 month ]
    assessed according to the pathology report of the operation specimen

  6. postoperative complications [ Time Frame: up to 6 months ]
    number of participants with postoperative complications graded by Clavien- Dindo system

  7. progression-free survival [ Time Frame: 12 months ]
  8. local recurrence [ Time Frame: 12 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
  • 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

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): NCT02326558


Locations
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China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
National Natural Science Foundation of China
Investigators
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Study Chair: Yi-Ran Huang, M.D. RenJi Hospital

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Responsible Party: Huang Yi-Ran, Chef of Urology, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02326558     History of Changes
Other Study ID Numbers: RenJiH-URO-001
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Huang Yi-Ran, RenJi Hospital:
zero ischemia
microwave
ablation
enucleation
renal cell carcinoma

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