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Off Clamp Randomization

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ClinicalTrials.gov Identifier: NCT01732120
Recruitment Status : Active, not recruiting
First Posted : November 22, 2012
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Midwest Stone Institute.
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Renal Cancer Renal Ischemia Procedure: Off-clamp partial nephrectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
Study Start Date : November 2012
Actual Primary Completion Date : May 31, 2017
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Renal function [ Time Frame: 3 months post nephrectomy ]

    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 :
  1. Oncologic outcomes [ Time Frame: 3 years ]

    Oncologic outcomes will be assessed based on:

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

  2. Perioperative outcomes [ Time Frame: 3 months ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.)

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): NCT01732120


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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01732120     History of Changes
Other Study ID Numbers: myIRB ID 201208091
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

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

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