Registry Study - Whipple at the Splenic Artery

Completed

• Conditions: Pancreas Cancer
• Interventions: Procedure: Whipple at the Splenic Artery (WATSA)

• Registration Number: NCT01155882
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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

* 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Study Start: 2010-09-20
• Status Verified: 2019-01
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Whipple Surgery at the Splenic Artery	Whipple at the Splenic Artery (WATSA)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Survival/recurrence at 2 years	2 years	To determine the survival/recurrence rates at 2 years.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States