Registry Study - Whipple at the Splenic Artery (WATSA)

The Washington University

Status: Completed

Conditions: Pancreas Cancer

Treatments: Procedure: Whipple at the Splenic Artery (WATSA)

Study type: Observational

Funder types: Other

Identifiers

NCT01155882

10-0767 / 201105335

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

13 participants in 1 patient group

Whipple Surgery at the Splenic Artery

Description:

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.

Treatment:

Procedure: Whipple at the Splenic Artery (WATSA)