Registry Study - Whipple at the Splenic Artery

Washington University School of Medicine13 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreas Cancer

Interventions

Whipple at the Splenic Artery (WATSA)PROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 day postoperative mortality

Secondary Outcomes

Survival/recurrence at 2 years

To determine the survival/recurrence rates at 2 years.

Time frame: 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.

Time frame: By CT scan at 8 weeks

Data from ClinicalTrials.gov

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