Zero Ischemia Laparoscopic Partial Nephrectomy

Small Renal Mass Clinical Trial

— ZILPAREMZ  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02634385
• Other study ID #: ZILPAREMBZ14
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 10, 2014
• Last updated: July 26, 2016
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Hamilton Integrated Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Small Renal Mass

Intervention

Procedure:
• Renal Artery Embolization
Patients will be receiving embolization prior to planned partial nephrectomy.
• Partial Nephrectomy (Surgical Resection)
Patients will be undergoing planned partial nephrectomy post embolization.

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	Extirpative time	From initial renal tissue breach until completion of bolster placement. Calculated in minutes.	Duration of Surgical Procedure	No
Primary	Warm ischemia time	From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.	Duration of Surgical Procedure	No
Primary	Mean estimated blood loss (measured in ml)	From the start of procedure (Nephrectomy), until the end of the procedure.	Duration of Surgical Procedure	No
Secondary	Mean hospital stay	Date admitted for procedure until date of discharge. Measure in calendar days.	2-10 Days	No
Secondary	Blood transfusions	Prior to Embolization procedure and pre and post-nephrectomy.	From date of pre-op up to 6 months post-op	No
Secondary	Conversion to other type of surgery (i.e. Radical Nephrectomy)	Minutes from the start of procedure (Nephrectomy).	Duration of Surgical Procedure	No
Secondary	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.	No
Secondary	Overall survival rates	Follow-up will be monitored.	Up to 24 months post-operatively.	No
Secondary	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.	No