WATSA: Registry Study - Whipple at the Splenic Artery

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01155882
Collaborator
(none)
13
1
99.9
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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.

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Cohort
Time Perspective:
Other
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
Actual Study Start Date :
Sep 20, 2010
Actual Primary Completion Date :
Jan 16, 2019
Actual Study Completion Date :
Jan 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Whipple Surgery at the Splenic Artery

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.

Procedure: Whipple at the Splenic Artery (WATSA)

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. Survival/recurrence at 2 years [2 years]

    To determine the survival/recurrence rates at 2 years.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Steven Strasberg, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01155882
Other Study ID Numbers:
  • 10-0767 / 201105335
First Posted:
Jul 2, 2010
Last Update Posted:
Jan 22, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2019