Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
13 participants
OBSERVATIONAL
2010-09-20
2019-01-16
Brief Summary
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Detailed Description
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The primary objective of this registry study is to collect clinical data from patients who undergo the WATSA procedure. Specific hypotheses to be tested are
* To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
* To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
Secondary
The secondary objectives of this registry study are to
* To determine the survival/recurrence rates at 2 years.
* To determine the effect of occlusion of the splenic vein at the confluence.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Whipple Surgery at the Splenic Artery
Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
Whipple at the Splenic Artery (WATSA)
Interventions
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Whipple at the Splenic Artery (WATSA)
Eligibility Criteria
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Inclusion Criteria
* Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis.
* Patient must be between 18 to 85 years of age.
* Patient must be a candidate for the WATSA procedure or have had the WATSA surgery performed within 1 year.
* Patient must be able to understand and willing to sign a written informed consent document.
Eligibility Criteria - Retrospective Portion:
Patient underwent WATSA procedure at our institution between 01/01/2009 and 12/31/2011.
18 Years
85 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Steven Strasberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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10-0767 / 201105335
Identifier Type: -
Identifier Source: org_study_id
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