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Zero Ischemia Laparoscopic Partial Nephrectomy (ZILPAREMZ)

Primary Purpose

Small Renal Mass

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Renal Artery Embolization
Partial Nephrectomy (Surgical Resection)
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Renal Mass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Small Renal Mass

Arm Description

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

Outcomes

Primary Outcome Measures

Extirpative time
From initial renal tissue breach until completion of bolster placement. Calculated in minutes.
Warm ischemia time
From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.
Mean estimated blood loss (measured in ml)
From the start of procedure (Nephrectomy), until the end of the procedure.

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2014
Last Updated
July 26, 2016
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02634385
Brief Title
Zero Ischemia Laparoscopic Partial Nephrectomy
Acronym
ZILPAREMZ
Official Title
Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No funding to start project.
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Renal Mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Small Renal Mass
Arm Type
No Intervention
Arm Description
Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
Renal Artery Embolization
Intervention Description
Patients will be receiving embolization prior to planned partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
Partial Nephrectomy (Surgical Resection)
Intervention Description
Patients will be undergoing planned partial nephrectomy post embolization.
Primary Outcome Measure Information:
Title
Extirpative time
Description
From initial renal tissue breach until completion of bolster placement. Calculated in minutes.
Time Frame
Duration of Surgical Procedure
Title
Warm ischemia time
Description
From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.
Time Frame
Duration of Surgical Procedure
Title
Mean estimated blood loss (measured in ml)
Description
From the start of procedure (Nephrectomy), until the end of the procedure.
Time Frame
Duration of Surgical Procedure
Secondary Outcome Measure Information:
Title
Mean hospital stay
Description
Date admitted for procedure until date of discharge. Measure in calendar days.
Time Frame
2-10 Days
Title
Blood transfusions
Description
Prior to Embolization procedure and pre and post-nephrectomy.
Time Frame
From date of pre-op up to 6 months post-op
Title
Conversion to other type of surgery (i.e. Radical Nephrectomy)
Description
Minutes from the start of procedure (Nephrectomy).
Time Frame
Duration of Surgical Procedure
Title
Identification of other complications (i.e. readmission, arteriovenous malformations)
Description
Complications will be monitored after patient is discharged up until two years post-operatively.
Time Frame
Up to 24 months post-operatively.
Title
Overall survival rates
Description
Follow-up will be monitored.
Time Frame
Up to 24 months post-operatively.
Title
Pathological Results (% of negative margins and benign versus malignant tumours).
Description
Pathology results are usually not released until 7-14 days post nephrectomy.
Time Frame
7 to 14 days post nephrectomy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada

12. IPD Sharing Statement

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Zero Ischemia Laparoscopic Partial Nephrectomy

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