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

Phase 3

• Conditions: Small Renal Masses
• Interventions: Procedure: Robotic Assisted Nephrectomy; Procedure: Laparoscopic Assisted Nephrectomy

• Registration Number: NCT02933398
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19
• Study Start: 2021-12
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Assisted Partial Nephrectomy	Robotic Assisted Nephrectomy	Current standard for partial nephrectomies.
Robotic Assisted Partial Nephrectomy	Laparoscopic Assisted Nephrectomy	Possible new standard for partial nephrectomies.

Primary Outcome Measures

Name	Time	Method
Warm ischemia time	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).

Secondary Outcome Measures

Name	Time	Method
Complication rates as per Clavien-Dindo classification	Up to 24 months post-operatively.	It will be recorded for the intra-operative, post-operative and follow-up period.
Estimated blood loss	Duration of the Surgical Procedure (Nephrectomy)	Will be measured intraoperatively from the amount of blood (ml) in the suction container.
Positive surgical margin rate	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).
Costs of treatment	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.
Conversion rate to radical nephrectomy or OPN due to technical difficulty.	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.
Postoperative pain	Minutes to hours after nephrectomy up to 3 months post-operatively.
eGFR	Up to 24 months post operatively.	It will be measured preoperatively, postoperatively and at each of the follow-up visit.
Length of hospital stay	3-7 Days	Calculated from day of admission to day of discharge from hospital.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton - McMaster Institute of Urology; 🇨🇦 Hamilton, Ontario, Canada