Registry Study - Whipple at the Splenic Artery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01155882

Acronym

WATSA

Enrollment

Registered

2010-07-02

Start date

2010-09-20

Completion date

2019-01-16

Last updated

2019-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

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.

Interventions

PROCEDUREWhipple at the Splenic Artery (WATSA)

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Survival/recurrence at 2 years	2 years	To determine the survival/recurrence rates at 2 years.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026