Off Clamp Randomization
This study is currently recruiting participants.
Verified May 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
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: May 6, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- decline in estimated glomerular filtration rate
- 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:
- pathological results
- 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:
- estimated blood loss
- operative time and warm ischemia time
- intra-operative complications
- length of postoperative hospital stay
- 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 aspirin, 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
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: | May 6, 2013 |
| 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 Ischemia Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013