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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


N/A
18 Years
85 Years
Open (Enrolling)
Both
Pancreas Cancer

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Trial Information

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


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.


Inclusion Criteria:



- Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas
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 6 months.

- Patient must be able to understand and willing to sign a written informed consent
document.

Exclusion Criteria:

-None

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Effectivity of the Whipple at the Splenic Artery

Outcome Description:

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.

Outcome Time Frame:

By CT scan at 8 weeks post surgery

Safety Issue:

No

Principal Investigator

Steven Strasberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

10-0767 / 201105335

NCT ID:

NCT01155882

Start Date:

September 2010

Completion Date:

August 2015

Related Keywords:

  • Pancreas Cancer
  • Pancreatic Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110