Off Clamp Randomization

Evaluation of the Off-Clamp Robot-Assisted Partial Nephrectomy Technique in the Management of Renal Tumors

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.

Study Overview

• Status: Completed
• Conditions: Renal Cancer; Renal Ischemia
• Intervention / Treatment: Procedure: Off-clamp partial nephrectomy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the time of nephrectomy
Estimated Blood Loss	Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.	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.	3 years
Operative Time Measured in Minutes.	Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.	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.	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.	At the time of nephrectomy
Number of Hospital Days Post Nephrectomy.	Perioperative outcomes will be assessed based number of hospital days post nephrectomy.	Day of nephrectomy to day of hospital discharge.
Percent of Observations With Postoperative Complications.	Perioperative outcomes will be assessed based on percent of observations with postoperative complications.	Within 3 months post nephrectomy.

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Midwest Stone Institute.
• Investigators: Principal Investigator: Robert S Figenshau, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 22, 2012

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: partial nephrectomy; off-clamp; renal cancer treatment; renal ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Ischemia
• Other Study ID Numbers: myIRB ID 201208091