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Trial record 28 of 6080 for:    zero

Zero Ischemia Laparoscopic Partial Nephrectomy (ZILPAREMZ)

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ClinicalTrials.gov Identifier: NCT02634385
Recruitment Status : Withdrawn (No funding to start project.)
First Posted : December 18, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Anil Kapoor, McMaster University

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.

Condition or disease Intervention/treatment Phase
Small Renal Mass Procedure: Renal Artery Embolization Procedure: Partial Nephrectomy (Surgical Resection) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial
Study Start Date : November 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
No Intervention: Small Renal Mass
Patient's with a small renal mass will be undergoing embolization prior to laparoscopic partial nephrectomy.
Procedure: Renal Artery Embolization
Patients will be receiving embolization prior to planned partial nephrectomy.

Procedure: Partial Nephrectomy (Surgical Resection)
Patients will be undergoing planned partial nephrectomy post embolization.




Primary Outcome Measures :
  1. Extirpative time [ Time Frame: Duration of Surgical Procedure ]
    From initial renal tissue breach until completion of bolster placement. Calculated in minutes.

  2. Warm ischemia time [ Time Frame: Duration of Surgical Procedure ]
    From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.

  3. Mean estimated blood loss (measured in ml) [ Time Frame: Duration of Surgical Procedure ]
    From the start of procedure (Nephrectomy), until the end of the procedure.


Secondary Outcome Measures :
  1. Mean hospital stay [ Time Frame: 2-10 Days ]
    Date admitted for procedure until date of discharge. Measure in calendar days.

  2. Blood transfusions [ Time Frame: From date of pre-op up to 6 months post-op ]
    Prior to Embolization procedure and pre and post-nephrectomy.

  3. Conversion to other type of surgery (i.e. Radical Nephrectomy) [ Time Frame: Duration of Surgical Procedure ]
    Minutes from the start of procedure (Nephrectomy).

  4. Identification of other complications (i.e. readmission, arteriovenous malformations) [ Time Frame: Up to 24 months post-operatively. ]
    Complications will be monitored after patient is discharged up until two years post-operatively.

  5. Overall survival rates [ Time Frame: Up to 24 months post-operatively. ]
    Follow-up will be monitored.

  6. Pathological Results (% of negative margins and benign versus malignant tumours). [ Time Frame: 7 to 14 days post nephrectomy. ]
    Pathology results are usually not released until 7-14 days post nephrectomy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634385


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Hamilton, Ontario, Canada, L8N4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton

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Responsible Party: Anil Kapoor, MD, FRCSC, McMaster University
ClinicalTrials.gov Identifier: NCT02634385     History of Changes
Other Study ID Numbers: ZILPAREMBZ14
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes