Clinical trial NCT02634385: Zero Ischemia Laparoscopic Partial Nephrectomy
Official title: Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Small Renal Mass
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Extirpative time
timeFrame: Duration of Surgical Procedure
measure: Warm ischemia time
timeFrame: Duration of Surgical Procedure
measure: Mean estimated blood loss (measured in ml)
timeFrame: Duration of Surgical Procedure
Secondary outcomes:
measure: Mean hospital stay
timeFrame: 2-10 Days
measure: Blood transfusions
timeFrame: From date of pre-op up to 6 months post-op
measure: Conversion to other type of surgery (i.e. Radical Nephrectomy)
timeFrame: Duration of Surgical Procedure
measure: Identification of other complications (i.e. readmission, arteriovenous malformations)
timeFrame: Up to 24 months post-operatively.
measure: Overall survival rates
timeFrame: Up to 24 months post-operatively.
measure: Pathological Results (% of negative margins and benign versus malignant tumours).
timeFrame: 7 to 14 days post nephrectomy.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
state: Ontario
Study officials:
References: