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Completed

NCT Number: NCT01155882

Registry Study - Whipple at the Splenic Artery

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whipple at the Splenic Artery (WATSA)

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Acronym: WATSA

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2010
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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