Registry Study - Whipple at the Splenic Artery

NCT01155882 | Completed

• 1 other identifier: 10-0767 / 201105335
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Survival/recurrence at 2 years

  2 years

• Effect of occlusion of the splenic vein at the confluence.

  By CT scan at 8 weeks

Study Arms (1)

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)

Interventions

Whipple at the Splenic Artery (WATSA) PROCEDURE

Whipple Surgery at the Splenic Artery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified from PI's patient population or referrals from colleagues.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Steven Strasberg, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 2, 2010
• Study Start: September 20, 2010
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)