Whipple Procedure: Standard of Care vs. Thunderbeat

Stopped early · Not applicable · Has a placebo group

Conditions studied: Pancreatic Neoplasms, Bile Duct Carcinoma

In brief

The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation, and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative morbidity (the presence of illness or disease). The findings will then be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.

Key facts

Study ID

NCT02204124

Run by

Washington University School of Medicine

People needed

44

Starts

2015-01-01

Expected to finish

2017-08-23

Last updated by the study team

2018-09-19

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo an elective open or laparoscopic Whipple procedure
• At least 22 years of age.
• Karnofsky performance status greater than or equal to 80%.
• Able to understand and willing to sign a written informed consent document.

You may not qualify if…

• Pregnant or breastfeeding.
• Surgeon's opinion at the time of dissection that the subject's well being (e.g. bleeding or other independent acute health problems) would be compromised.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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