A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses (RALPLPNNX)

March 17, 2021 updated by: Anil Kapoor, St. Joseph's Healthcare Hamilton

A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.

A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (<4 cm) amenable to resection using either RALPN or LPN.

Study Overview

Detailed Description

Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.

The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
        • St. Joseph's Healthcare Hamilton - McMaster Institute of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients at least 18 years of age and capable of giving informed consent
  2. Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
  3. Patients with SRMs (tumor(s) ≤ 4 cm)

Exclusion Criteria:

  1. Large tumors > 4.0cm
  2. Unable to have a general anesthetic
  3. Unable to comply with post-operative follow-up protocol
  4. Uncorrectable bleeding diathesis
  5. Tumors unsuitable for LPN/RALPN technique
  6. Evidence of metastatic disease
  7. Prior surgery on the affected kidney
  8. Ectopic or malrotated kidney
  9. Mental health condition that precludes informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic Assisted Partial Nephrectomy
Current standard for partial nephrectomies.
Robotic (Davinci)
Active Comparator: Robotic Assisted Partial Nephrectomy
Possible new standard for partial nephrectomies.
Regular Laparoscopic Technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Warm ischemia time
Time Frame: Duration of the Surgical Procedure (Nephrectomy)
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
Duration of the Surgical Procedure (Nephrectomy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR
Time Frame: Up to 24 months post operatively.
It will be measured preoperatively, postoperatively and at each of the follow-up visit.
Up to 24 months post operatively.
Estimated blood loss
Time Frame: Duration of the Surgical Procedure (Nephrectomy)
Will be measured intraoperatively from the amount of blood (ml) in the suction container.
Duration of the Surgical Procedure (Nephrectomy)
Complication rates as per Clavien-Dindo classification
Time Frame: Up to 24 months post-operatively.
It will be recorded for the intra-operative, post-operative and follow-up period.
Up to 24 months post-operatively.
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
Time Frame: Duration of the Surgical Procedure
From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy.
Duration of the Surgical Procedure
Postoperative pain
Time Frame: Minutes to hours after nephrectomy up to 3 months post-operatively.
Minutes to hours after nephrectomy up to 3 months post-operatively.
Length of hospital stay
Time Frame: 3-7 Days
Calculated from day of admission to day of discharge from hospital.
3-7 Days
Positive surgical margin rate
Time Frame: 14 days
Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery. Distance to surgical margin will be looked at (mm to cm).
14 days
Costs of treatment
Time Frame: Up to 1 year
Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St. Joseph Healthcare case-costing system. The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care. The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • RALPLPNNX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Renal Masses

Clinical Trials on Robotic Assisted Nephrectomy

3
Subscribe