Zero Ischemia Laparoscopic Partial Nephrectomy

NCT02634385 | Withdrawn Phase 2

• 1 other identifier: ZILPAREMBZ14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic skill. Renal vessel clamp for vascular control is a required step during standard LPN. However, this creates a time limiting step for the surgeon and induces renal injury via warm ischemia and reperfusion injury. This novel approach can substantially reduce renal injury during LPN via superselective embolization of level II renal arteries pre-operatively. This technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly simplifying the procedure by remove time thresholds within which to perform tumor excision. The preliminary results are promising; however, there is a need for further corroboration of their results, in addition to a randomized controlled trial comparing this modified, zero ischemia technique with standard LPN.

Conditions

Small Renal Mass

Outcome Measures

Primary Outcomes (3)

• Extirpative time

  From initial renal tissue breach until completion of bolster placement. Calculated in minutes.

  Duration of Surgical Procedure

• Warm ischemia time

  From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.

  Duration of Surgical Procedure

• Mean estimated blood loss (measured in ml)

  From the start of procedure (Nephrectomy), until the end of the procedure.

  Duration of Surgical Procedure

Secondary Outcomes (6)

• Mean hospital stay

  2-10 Days

• Blood transfusions

  From date of pre-op up to 6 months post-op

• Conversion to other type of surgery (i.e. Radical Nephrectomy)

  Duration of Surgical Procedure

• Identification of other complications (i.e. readmission, arteriovenous malformations)

  Up to 24 months post-operatively.

• Overall survival rates

  Up to 24 months post-operatively.

Study Arms (1)

Small Renal Mass

NO INTERVENTION

Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy.

Procedure: Renal Artery Embolization; Procedure: Partial Nephrectomy (Surgical Resection)

Interventions

Renal Artery Embolization PROCEDURE

Patients will be receiving embolization prior to planned partial nephrectomy.

Small Renal Mass

Partial Nephrectomy (Surgical Resection) PROCEDURE

Patients will be undergoing planned partial nephrectomy post embolization.

Small Renal Mass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T1a renal cell carcinomas diagnosed by ultrasonography (US), computed tomography (CT) or fine needle aspiration
• tumor size \<4cm in diameter
• predominant exophytic growth
• intraparenchymal depth no greater than 1.5cm, with a minimum distance of 5mm from the urinary collecting system

You may not qualify if:

• predominant endophytic nature (depth \</= 1.5 cm)
• nearness (\<0.5cm) of the tumor to the urinary collecting system
• multiple ipsilateral lesions
• pregnancy
• allergy to intravenous contrast dye
• absolute contraindications to surgical intervention

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton - McMaster Institute of Urology

Hamilton, Ontario, L8N4A6, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: December 18, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

CA (1)