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Registry Study - Whipple at the Splenic Artery (WATSA)

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ClinicalTrials.gov Identifier: NCT01155882
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).

Condition or disease Intervention/treatment
Pancreas Cancer 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
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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 : September 20, 2010
Actual Primary Completion Date : January 16, 2019
Actual Study Completion Date : January 16, 2019

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Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Effectivity of the Whipple at the Splenic Artery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]
    To determine the survival/recurrence rates at 2 years.

  2. Effect of occlusion of the splenic vein at the confluence. [ Time Frame: By CT scan at 8 weeks ]
    To determine the effect of occlusion of the splenic vein at the confluence.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be identified from PI's patient population or referrals from colleagues.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155882


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Steven Strasberg, M.D. Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01155882    
Other Study ID Numbers: 10-0767 / 201105335
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases