Zero Ischemia Laparoscopic Partial Nephrectomy (ZILPAREMZ)

Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Small Renal Mass
• Intervention / Treatment: Procedure: Renal Artery Embolization; Procedure: Partial Nephrectomy (Surgical Resection)

Detailed Description

The potential utility of a zero ischemia, laparoscopic, partial nephrectomy portends significant implications for both the surgeon and patient. Firstly, the technical difficulty of a partial nephrectomy will be reduced to a more achievable level owing mainly to the removal of a time limit on surgical resection. With the blood flow halted to downstream tissue containing the renal neoplasm from preoperative embolization, resection can be made to the tumor without clamping of the main renal arteries. This minimizes the ischemic time to non-neoplastic renal tissue, allowing for a renal protective effect. Without the need for clamping, the overall surgical operative time is drastically reduced. With excision made at the ischemic tissue, intra-operative bleeding and ease can be achieved. More surgeons can ultimately attempt at LPN by removing the single most limiting surgical factor, warm ischemic time.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Small Renal Mass; Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy.	Procedure: Renal Artery Embolization; Patients will be receiving embolization prior to planned partial nephrectomy.; Procedure: Partial Nephrectomy (Surgical Resection); Patients will be undergoing planned partial nephrectomy post embolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean hospital stay	Date admitted for procedure until date of discharge. Measure in calendar days.	2-10 Days
Blood transfusions	Prior to Embolization procedure and pre and post-nephrectomy.	From date of pre-op up to 6 months post-op
Conversion to other type of surgery (i.e. Radical Nephrectomy)	Minutes from the start of procedure (Nephrectomy).	Duration of Surgical Procedure
Identification of other complications (i.e. readmission, arteriovenous malformations)	Complications will be monitored after patient is discharged up until two years post-operatively.	Up to 24 months post-operatively.
Overall survival rates	Follow-up will be monitored.	Up to 24 months post-operatively.
Pathological Results (% of negative margins and benign versus malignant tumours).	Pathology results are usually not released until 7-14 days post nephrectomy.	7 to 14 days post nephrectomy.

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Estimate): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: ZILPAREMBZ14