Registry Study - Whipple at the Splenic Artery

Pancreas Cancer Clinical Trial

— WATSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155882
• Other study ID #: 10-0767 / 201105335
• Status: Completed
• Start date: September 20, 2010
• Est. completion date: January 16, 2019

Study information

• Verified date: January 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Whipple at the Splenic Artery (WATSA)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectivity of the Whipple at the Splenic Artery	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.	By CT scan at 8 weeks post surgery
Primary	To determine range of morbidity and 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.	30 day postoperative mortality
Secondary	Survival/recurrence at 2 years	To determine the survival/recurrence rates at 2 years.	2 years
Secondary	Effect of occlusion of the splenic vein at the confluence.	To determine the effect of occlusion of the splenic vein at the confluence.	By CT scan at 8 weeks

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine