Registry Study - Whipple at the Splenic Artery

NCT ID: NCT01155882

Last Updated: 2019-01-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-20

Study Completion Date

2019-01-16

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.

Conditions

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Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type PROCEDURE

Interventions

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Whipple at the Splenic Artery (WATSA)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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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