Zero Ischemia Laparoscopic Partial Nephrectomy (ZILPAREMZ)

St. Joseph's Healthcare Hamilton

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Small Renal Mass

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02634385

ZILPAREMBZ14

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Small Renal Mass

No Intervention group

Description:

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

Treatment:

Procedure: Partial Nephrectomy (Surgical Resection)

Procedure: Renal Artery Embolization