Whipple at the Splenic Artery - A Procedure for Ductal Adenocarcinoma of the Pancreas With Extensive Involvement of the Porto-Mesenteric Axis: A Registry Study
18 Years
85 Years
Both
Pancreas Cancer
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 Medicine | Saint Louis, Missouri 63110 |
