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Registry Study - Whipple at the Splenic Artery (WATSA)

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ClinicalTrials.gov Identifier: NCT01155882
Recruitment Status : Recruiting
First Posted : July 2, 2010
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 Type : Observational
Estimated Enrollment : 25 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
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2025

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)



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.



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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.


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


Contacts
Contact: Steven Strasberg, MD 314-362-7147 strasbergs@wustl.edu
Contact: Tracey J Guthrie 314-747-4404 guthriet@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Steven Strasberg, MD    314-362-7147    strasbergs@wustl.edu   
Contact: Tracey J Guthrie    314-747-4404    guthriet@wustl.edu   
Sub-Investigator: Steven Strasberg, M.D.         
Sub-Investigator: Luis Sanchez, M.D.         
Sub-Investigator: Sanjeev Bhalla, M.D.         
Sub-Investigator: Joel Picus, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Benjamin Tan, M.D.         
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Riad Azar, M         
Sub-Investigator: Daniel Mullady, M.D.         
Sub-Investigator: Dayna Early, M.D.         
Sub-Investigator: Feng Gao, Ph.D.         
Sub-Investigator: William Hawkins, M.D.         
Sub-Investigator: Ryan C Fields, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Steven Strasberg, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01155882     History of Changes
Other Study ID Numbers: 10-0767 / 201105335
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases