Skip to content

Zero Ischemia Laparoscopic Partial Nephrectomy

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

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02634385
Acronym
ZILPAREMZ
Enrollment
0
Registered
2015-12-18
Start date
2015-11-30
Completion date
2016-06-30
Last updated
2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Renal Mass

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.

Interventions

Patients will be receiving embolization prior to planned partial nephrectomy.

PROCEDUREPartial Nephrectomy (Surgical Resection)

Patients will be undergoing planned partial nephrectomy post embolization.

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Identification of other complications (i.e. readmission, arteriovenous malformations)Up to 24 months post-operatively.Complications will be monitored after patient is discharged up until two years post-operatively.
Mean hospital stay2-10 DaysDate admitted for procedure until date of discharge. Measure in calendar days.
Pathological Results (% of negative margins and benign versus malignant tumours).7 to 14 days post nephrectomy.Pathology results are usually not released until 7-14 days post nephrectomy.
Overall survival ratesUp to 24 months post-operatively.Follow-up will be monitored.
Blood transfusionsFrom date of pre-op up to 6 months post-opPrior to Embolization procedure and pre and post-nephrectomy.
Conversion to other type of surgery (i.e. Radical Nephrectomy)Duration of Surgical ProcedureMinutes from the start of procedure (Nephrectomy).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026