WATSA: Registry Study - Whipple at the Splenic Artery
Study Details
Study Description
Brief Summary
The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Primary
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
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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.
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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
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To determine the survival/recurrence rates at 2 years.
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To determine the effect of occlusion of the splenic vein at the confluence.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Procedure: Whipple at the Splenic Artery (WATSA)
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Outcome Measures
Primary Outcome Measures
- Effectivity of the Whipple at the Splenic Artery [By CT scan at 8 weeks post surgery]
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 range of morbidity and mortality [30 day postoperative mortality]
To determine if Whipple at the splenic artery can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
Secondary Outcome Measures
- Survival/recurrence at 2 years [2 years]
To determine the survival/recurrence rates at 2 years.
- Effect of occlusion of the splenic vein at the confluence. [By CT scan at 8 weeks]
To determine the effect of occlusion of the splenic vein at the confluence.
Eligibility Criteria
Criteria
Eligibility Criteria - Prospective Portion:
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Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis.
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Patient must be between 18 to 85 years of age.
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Patient must be a candidate for the WATSA procedure or have had the WATSA surgery performed within 1 year.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Steven Strasberg, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 10-0767 / 201105335