Off Clamp Randomization

Renal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732120
• Other study ID #: myIRB ID 201208091
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Ischemia
• Kidney Neoplasms
• Renal Cancer
• Renal Ischemia

Intervention

Procedure:
• Off-clamp partial nephrectomy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Midwest Stone Institute.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Estimated Blood Loss	Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.	At the time of nephrectomy
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Percent of Observations With Postoperative Complications.	Perioperative outcomes will be assessed based on percent of observations with postoperative complications.	Within 3 months post nephrectomy.