Off Clamp Randomization

Not Applicable

Completed

• Conditions: Renal Ischemia; Renal Cancer
• Interventions: Procedure: Off-clamp partial nephrectomy

• Registration Number: NCT01732120
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Primary Completion: 2017-05-31
• Study Completion: 2020-12-31
• Results First Submitted: 2022-03-09
• Results First Submitted QC: 2022-03-09
• Results First Posted: 2022-06-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Off-clamp partial nephrectomy	Off-clamp partial nephrectomy	Partial nephrectomy will be performed without clamping of the renal blood vessels.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States