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

Small Renal Masses Clinical Trial

— RALPLPNNX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933398
• Other study ID #: RALPLPNNX
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: Anil Kapoor, MD, FRCSC
• Phone: 905-522-1155
• Email: akapoor[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small Renal Masses

Intervention

Procedure:
• Robotic Assisted Nephrectomy
Robotic (Davinci)
• Laparoscopic Assisted Nephrectomy
Regular Laparoscopic Technique.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton - McMaster Institute of Urology	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

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