Registry Study - Whipple At The Splenic Artery | National Pancreatic Cancer Foundation

Study Overview

Registry Study - Whipple at the Splenic Artery

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

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.

Pancreas Cancer

PROCEDURE: Whipple at the Splenic Artery (WATSA)

10-0767 / 201105335

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-06-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-17
First Submitted that Met QC Criteria 2010-07-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-22
First Posted (ACTUAL) 2010-07-02	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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)

Participant Group/Arm

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	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Survival/recurrence at 2 years	To determine the survival/recurrence rates at 2 years.	2 years
Effect of occlusion of the splenic vein at the confluence.	To determine the effect of occlusion of the splenic vein at the confluence.	By CT scan at 8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Steven Strasberg, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record