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Off Clamp Randomization

Primary Purpose

Renal Cancer, Renal Ischemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Off-clamp partial nephrectomy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancer focused on measuring off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Off-clamp partial nephrectomy

Traditional partial nephrectomy

Arm Description

Partial nephrectomy will be performed without clamping of the renal blood vessels.

Partial nephrectomy will be performed with clamping of the renal blood vessels.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in eGFR
Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
Percent Change From Baseline in Split Renal Function
Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.

Secondary Outcome Measures

Percent of Observations With Positive Surgical Margins.
Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.
Estimated Blood Loss
Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.
Percent of Observations With Metastasis
Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.
Operative Time Measured in Minutes.
Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.
Warm Ischemia Time Measured in Minutes.
Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.
Percent of Observations With Intra-operative Complications.
Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.
Number of Hospital Days Post Nephrectomy.
Perioperative outcomes will be assessed based number of hospital days post nephrectomy.
Percent of Observations With Postoperative Complications.
Perioperative outcomes will be assessed based on percent of observations with postoperative complications.

Full Information

First Posted
November 16, 2012
Last Updated
July 19, 2022
Sponsor
Washington University School of Medicine
Collaborators
Midwest Stone Institute.
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1. Study Identification

Unique Protocol Identification Number
NCT01732120
Brief Title
Off Clamp Randomization
Official Title
Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Midwest Stone Institute.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer, Renal Ischemia
Keywords
off-clamp, partial nephrectomy, renal cancer treatment, renal ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Off-clamp partial nephrectomy
Arm Type
Experimental
Arm Description
Partial nephrectomy will be performed without clamping of the renal blood vessels.
Arm Title
Traditional partial nephrectomy
Arm Type
No Intervention
Arm Description
Partial nephrectomy will be performed with clamping of the renal blood vessels.
Intervention Type
Procedure
Intervention Name(s)
Off-clamp partial nephrectomy
Primary Outcome Measure Information:
Title
Percent Change From Baseline in eGFR
Description
Renal function following nephrectomy with and without clamping will be assessed using: percent change in eGFR from baseline to 3 months post nephrectomy.
Time Frame
baseline and 3 months post nephrectomy
Title
Percent Change From Baseline in Split Renal Function
Description
Renal function following nephrectomy with and without clamping will be assessed using: percent change in split renal function from baseline to 3 months post nephrectomy.
Time Frame
baseline to 3 months post nephrectomy
Secondary Outcome Measure Information:
Title
Percent of Observations With Positive Surgical Margins.
Description
Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.
Time Frame
at the time of nephrectomy
Title
Estimated Blood Loss
Description
Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.
Time Frame
At the time of nephrectomy
Title
Percent of Observations With Metastasis
Description
Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.
Time Frame
3 years
Title
Operative Time Measured in Minutes.
Description
Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.
Time Frame
At the time of nephrectomy
Title
Warm Ischemia Time Measured in Minutes.
Description
Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.
Time Frame
At the time of nephrectomy.
Title
Percent of Observations With Intra-operative Complications.
Description
Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.
Time Frame
At the time of nephrectomy
Title
Number of Hospital Days Post Nephrectomy.
Description
Perioperative outcomes will be assessed based number of hospital days post nephrectomy.
Time Frame
Day of nephrectomy to day of hospital discharge.
Title
Percent of Observations With Postoperative Complications.
Description
Perioperative outcomes will be assessed based on percent of observations with postoperative complications.
Time Frame
Within 3 months post nephrectomy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Figenshau, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Off Clamp Randomization

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