Whipple Procedure: Standard of Care vs. Thunderbeat

NCT02204124 | Terminated Results DMC FDA Device

• 1 other identifier: 201311146
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Neoplasms; Bile Duct Carcinoma

Keywords

Whipple procedure

Outcome Measures

Primary Outcomes (2)

• Operative Blood Loss

  * The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia notes where (EBL) is recorded during each surgical procedure * The estimate of operative blood loss is measured by volume in the suction canisters and pads and is historically documented by the operative nursing staff during the operation.

  Day of surgery

• Post-op Morbidity

  -This is a prospective study to evaluate post-operative morbidity following use of the ThunderbeatTM device during the Whipple procedure. This will be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.

  Up to 90 days postoperatively

Secondary Outcomes (5)

• Operative Time

  Day of surgery

• Cost Using Thunderbeat Device

  Up to 90 days postoperatively

• Anesthesia Time

  Day of surgery

• Number of Participants Who Experienced Perioperative Complications

  Day of surgery

• Number of Participants Who Experienced Postoperative Complications

  Up to 90 days postoperatively

Study Arms (2)

Control Group

ACTIVE COMPARATOR

In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.

Device: Standard of care scissors, ligatures, clips, and sutures

Thunderbeat™

EXPERIMENTAL

-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).

Device: Thunderbeat

Interventions

Thunderbeat DEVICE

Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.

Thunderbeat™

Standard of care scissors, ligatures, clips, and sutures DEVICE

Control Group

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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; Bile Duct Neoplasms

Interventions

Ligation; Surgical Instruments; Sutures

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Results Point of Contact

• Title: William Hawkins, M.D.
• Organization: Washington University School of Medicine

hawkinsw@wustl.edu

314-286-0702

Study Officials

• William Hawkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be blinded to the assigned operating technique.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 30, 2014
• Study Start: January 1, 2015
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)