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Trial record 24 of 5988 for:    zero

Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage

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ClinicalTrials.gov Identifier: NCT02734329
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : May 3, 2016
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Changhai Hospital
Shanghai 6th People's Hospital
Fudan University
Information provided by (Responsible Party):
Yiran Huang, RenJi Hospital

Brief Summary:
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.

Condition or disease Intervention/treatment Phase
Kidney Neoplasms Procedure: conventional laparoscopic partial nephrectomy Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: Zero Ischemia group
Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases.
Procedure: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)
Active Comparator: Conventional group
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
Procedure: conventional laparoscopic partial nephrectomy
renal artery will be clamped during surgery.




Primary Outcome Measures :
  1. the change in glomerular filtration rate (GFR) of the affected kidney [ Time Frame: Baseline and 30 months ]
  2. changes of estimated GFR (eGFR) [ Time Frame: Baseline and 30 months ]

Secondary Outcome Measures :
  1. estimated blood loss [ Time Frame: during surgery ]
  2. rates of positive surgical margin [ Time Frame: postoperative,up to 2 weeks after surgery ]
  3. postoperative complications [ Time Frame: postoperative,up to 30 days ]
  4. the rate of local recurrence [ Time Frame: through study completion, an average of 3 years ]
  5. operative time [ Time Frame: During surgery ]
  6. Hospital stay time [ Time Frame: The time from the surgery day to patient discharge, up to 2 weeks ]
  7. progression-free survival rate [ Time Frame: through study completion, an average of 3 years ]


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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 T1 presumed renal cell carcinoma
  • patients scheduled for laparoscopic nephron sparing surgery
  • 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 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): NCT02734329


Contacts
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Contact: jiwei huang, M.D. 862168383776 jiweihuang@outlook.com

Locations
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China
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, China, 200127
Contact: jiwei huang, M.D    86-21-68383716    jiweihuang@outlook.com   
Principal Investigator: Yiran Huang, M.D         
Sponsors and Collaborators
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Changzheng Hospital
Changhai Hospital
Shanghai 6th People's Hospital
Fudan University

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Responsible Party: Yiran Huang, Director of Urology, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02734329     History of Changes
Other Study ID Numbers: RenJiH-2016006
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Yiran Huang, RenJi Hospital:
Nephron sparing surgery
Zero ischemia
Warm ischemia
Laparoscopic
Radiofrequency ablation
Microwave ablation

Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases