Trial record 1 of 1 for:    Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
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Off Clamp Randomization

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Midwest Stone Institute.
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01732120
First received: November 16, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The purpose of this research study is to compare the effects on kidney function after performing the removal of a kidney tumor with or without clamping the blood vessels during surgery.


Condition Intervention
Renal Cancer
Renal Ischemia
Procedure: Off-clamp partial nephrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Renal function [ Time Frame: 3 months post nephrectomy ] [ Designated as safety issue: No ]

    Renal function following nephrectomy with and without clamping will be assessed using:

    1. decline in estimated glomerular filtration rate
    2. decline in split renal function


Secondary Outcome Measures:
  • Oncologic outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Oncologic outcomes will be assessed based on:

    1. pathological results
    2. evidence of disease recurrence or metastasis on follow-up imaging

  • Perioperative outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Perioperative outcomes will be assessed based on:

    1. estimated blood loss
    2. operative time and warm ischemia time
    3. intra-operative complications
    4. length of postoperative hospital stay
    5. postoperative complications


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Off-clamp partial nephrectomy
Partial nephrectomy will be performed without clamping of the renal blood vessels.
Procedure: Off-clamp partial nephrectomy
No Intervention: Traditional partial nephrectomy
Partial nephrectomy will be performed with clamping of the renal blood vessels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 and older.
  • Patients willing and able to sign consent.
  • Patients with an organ confined renal mass planning to undergo a robotic assisted partial nephrectomy (RAPN).
  • Patient with Karnofsky Performance Status (KPS) equal to or greater than 40.

Exclusion Criteria:

  • Patients under 18.
  • Patients with Karnofsky Performance Status (KPS) less than 40.
  • Patients with non-organ confined renal masses (invading renal vein, inferior vena cava, peri-renal tissue, ipsilateral adrenal gland, or metastasis).
  • Patients with bilateral synchronous renal masses.
  • Patients who can not discontinue Plavix, Coumadin or other anti-platelet or anti-coagulant medications.
  • Patients with renal lesions determined to be too complex to perform a RAPN without clamp by the surgeon. (The renal mass may be deemed too difficult based on pre-operatively radiological findings. The surgeon's decision to exclude a mass from a robotic assisted partial nephrectomy would be based on a higher risk of positive margin or complication if a RAPN was performed.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732120

Contacts
Contact: Aleksandra P Klim, MHS 314-747-9781 klima@wudosis.wuslt.edu
Contact: Karla Bergeron 314-454-7325 bergeronk@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Robert S Figenshau, MD         
Sponsors and Collaborators
Washington University School of Medicine
Midwest Stone Institute.
Investigators
Principal Investigator: Robert S Figenshau, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01732120     History of Changes
Other Study ID Numbers: myIRB ID 201208091
Study First Received: November 16, 2012
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
off-clamp
partial nephrectomy
renal cancer treatment
renal ischemia

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Ischemia
Adenocarcinoma
Carcinoma
Urologic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014