Registry Study - Whipple at the Splenic Artery

Study Overview
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Brief Summary
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The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).

Detailed Description
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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 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.

Official Title
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Whipple at the Splenic Artery - A Procedure for Ductal Adenocarcinoma of the Pancreas With Extensive Involvement of the Porto-Mesenteric Axis: A Registry Study

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Procedure: Whipple at the Splenic Artery (WATSA)


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria - Prospective Portion: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Whipple Surgery at the Splenic Artery<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectivity of the Whipple at the Splenic Artery | 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. | By CT scan at 8 weeks post surgery | 
| To determine range of morbidity and 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. | 30 day postoperative mortality | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival/recurrence at 2 years | To determine the survival/recurrence rates at 2 years. | 2 years | 
| Effect of occlusion of the splenic vein at the confluence. | To determine the effect of occlusion of the splenic vein at the confluence. | By CT scan at 8 weeks |