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OpenTrials
Completed

NCT Number: NCT01732120

Off Clamp Randomization

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.

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Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Ischemia Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Off-clamp partial nephrectomy

Procedure

Primary outcomes

  1. Percent Change From Baseline in eGFR

    Time frame: 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.

  2. Percent Change From Baseline in Split Renal Function

    Time frame: 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.

Secondary outcomes

  1. Percent of Observations With Positive Surgical Margins.

    Time frame: at the time of nephrectomy

    Oncologic outcomes will be assessed at the time of nephrectomy based on percent of observations with positive surgical margins.

  2. Estimated Blood Loss

    Time frame: At the time of nephrectomy

    Perioperative outcomes will be assessed based on estimated blood loss at the time of nephrectomy.

  3. Percent of Observations With Metastasis

    Time frame: 3 years

    Oncologic outcomes will be assessed based on percent of observations with metastasis on follow-up imaging at 3 years post nephrectomy.

  4. Operative Time Measured in Minutes.

    Time frame: At the time of nephrectomy

    Perioperative outcomes will be assessed based on operative time measured in minutes at the time of nephrectomy.

  5. Warm Ischemia Time Measured in Minutes.

    Time frame: At the time of nephrectomy.

    Perioperative outcomes will be assessed based on warm ischemia time measured in minutes at the time of nephrectomy.

  6. Percent of Observations With Intra-operative Complications.

    Time frame: At the time of nephrectomy

    Perioperative outcomes will be assessed based on percent of observations with intra-operative complications at the time of nephrectomy.

  7. Number of Hospital Days Post Nephrectomy.

    Time frame: Day of nephrectomy to day of hospital discharge.

    Perioperative outcomes will be assessed based number of hospital days post nephrectomy.

  8. Percent of Observations With Postoperative Complications.

    Time frame: Within 3 months post nephrectomy.

    Perioperative outcomes will be assessed based on percent of observations with postoperative complications.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Midwest Stone Institute.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2020
First posted
Nov 22, 2012
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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