Off Clamp Randomization

NCT01732120 | Completed Results DMC

• 1 other identifier: myIRB ID 201208091
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cancer; Renal Ischemia

Keywords

off-clamp; partial nephrectomy; renal cancer treatment; renal ischemia

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and 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.

  baseline to 3 months post nephrectomy

Secondary Outcomes (8)

• Percent of Observations With Positive Surgical Margins.

  at the time of nephrectomy

• Estimated Blood Loss

  At the time of nephrectomy

• Percent of Observations With Metastasis

  3 years

• Operative Time Measured in Minutes.

  At the time of nephrectomy

• Warm Ischemia Time Measured in Minutes.

  At the time of nephrectomy.

Study Arms (2)

Off-clamp partial nephrectomy

EXPERIMENTAL

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

Procedure: Off-clamp partial nephrectomy

Traditional partial nephrectomy

NO INTERVENTION

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

Interventions

Off-clamp partial nephrectomy PROCEDURE

Off-clamp partial nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Midwest Stone Institute.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Manager of Clinical Trials
• Organization: Washington University School of Medicine

klima@wustl.edu

3147479781

Study Officials

• Robert S Figenshau, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 22, 2012
• Study Start: November 1, 2012
• Primary Completion: May 31, 2017
• Study Completion: December 31, 2020
• Last Updated: May 19, 2023
• Results First Posted: June 9, 2022

Record last verified: 2022-07

Locations

US (1)