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Registry Study - Whipple at the Splenic Artery (WATSA)

This study is currently recruiting participants.
Verified December 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01155882
First received: June 30, 2010
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Pancreas Cancer
 Procedure: Whipple at the Splenic Artery (WATSA)

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine how effective Whipple at the Splenic Artery [ Time Frame: By CT scan at 8 weeks post surgery ] [ Designated as safety issue: No ]
    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 range of morbidity and mortality [ Time Frame: 30 day postoperative mortality ] [ Designated as safety issue: No ]
    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:
  • Survival/recurrence at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the survival/recurrence rates at 2 years.

  • Effect of occlusion of the splenic vein at the confluence. [ Time Frame: By CT scan at 8 weeks ] [ Designated as safety issue: No ]
    To determine the effect of occlusion of the splenic vein at the confluence.


Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155882

Contacts
Contact: Laura Daigh, BA 314-362-8547 daighl@wudosis.wustl.edu
Contact: Kirsten Cady, BS, CCRP 314-362-7773 cadyk@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Laura Daigh, BA     314-362-8547     daighl@wudosis.wustl.edu    
Contact: Kirsten Cady, BS, CCRP     314-362-7773     cadyk@wudosis.wustl.edu    
Sub-Investigator: David Linehan, M.D.            
Sub-Investigator: William Hawkins, M.D.            
Sub-Investigator: Luis Sanchez, M.D.            
Sub-Investigator: Sanjeev Bhalla, M.D.            
Sub-Investigator: A. Craig Lockhart, M.D.            
Sub-Investigator: Joel Picus, M.D.            
Sub-Investigator: Steven Sorscher, 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: Steven Edmundowicz, M.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: Faris Murad, M.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Steven Strasberg, M.D. Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01155882     History of Changes
Other Study ID Numbers: 10-0767 / 201105335
Study First Received: June 30, 2010
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013