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

• Sponsor: St. Joseph's Healthcare Hamilton (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT02933398
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Renal Masses	Procedure: Robotic Assisted Nephrectomy; Procedure: Laparoscopic Assisted Nephrectomy	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
• Anticipated Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. eGFR [Up to 24 months post operatively.]

   It will be measured preoperatively, postoperatively and at each of the follow-up visit.

2. Estimated blood loss [Duration of the Surgical Procedure (Nephrectomy)]

   Will be measured intraoperatively from the amount of blood (ml) in the suction container.

3. 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.

4. 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.

5. Postoperative pain [Minutes to hours after nephrectomy up to 3 months post-operatively.]

6. Length of hospital stay [3-7 Days]

   Calculated from day of admission to day of discharge from hospital.

7. 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).

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Healthcare Hamilton - McMaster Institute of Urology	Hamilton	Ontario	Canada	L8N4A6

Sponsors and Collaborators

• St. Joseph's Healthcare Hamilton

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anil Kapoor, MD, FRCSC, McMaster University
• ClinicalTrials.gov Identifier: NCT02933398
• Other Study ID Numbers: RALPLPNNX
• First Posted: Oct 14, 2016
• Last Update Posted: Mar 19, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 19, 2021