- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02204124
Whipple Procedure: Standard of Care vs. Thunderbeat
Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As the pancreas is fed by many vessels, it is necessary to use lots of ligatures, clips and sutures for hemostasis after dissection. This dissection technique is very time consuming and requires numerous changes of instruments. The devices the investigators currently have available for use in the operating suite are EnSeal and LigaSure. A new type of surgical scissors that delivers ultrasonically generated frictional heat energy and electrically generated bipolar energy simultaneously, known as the Thunderbeat™ (Olympus, Japan), is now an available alternative for dissection and hemostasis.
Thunderbeat™ was provided FDA clearance in March 2012 for use in open, laparoscopic, and endoscopic surgery, or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed.
The Thunderbeat™ device provides the first integration of both bipolar and ultrasonic energies delivered simultaneously from a single multi-functional instrument. This integration provides the surgeon the ability to rapidly cut tissue with ultrasonic energy and to create reliable vessel seals with bipolar energy without having to change devices. The current is provided by a special generator and contains a very high capacity with a low voltage. The body's proteins, such as collagen and elastin, are converted so a permanently sealed zone results. As the tissue between the branches is sealed, lateral thermic tissue damages can be limited to a minimum. Several authors have described a tendency of reduced intraoperative blood loss with bipolar energy devices. Other trials show reduced operating time when a bipolar device is utilized in several surgical procedures, such as thyroid, hepatic, urologic, hemorrhoidectomy and gynecology surgery.
Correct dissection in the operating field is very important to avert secondary bleeding or other complications, which might cause re-operation or elevate the patients' morbidity and mortality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control Group
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
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EXPERIMENTAL: Thunderbeat™
-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
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Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative Blood Loss
Time Frame: Day of surgery
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Day of surgery
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Post-op Morbidity
Time Frame: Up to 90 days postoperatively
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-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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative Time
Time Frame: Day of surgery
|
-Operation time measured from the beginning of the surgical procedure (incision of the skin) to the end of the surgical procedure (closure of the skin).
|
Day of surgery
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Cost Using Thunderbeat Device
Time Frame: Up to 90 days postoperatively
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-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively
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Up to 90 days postoperatively
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Anesthesia Time
Time Frame: Day of surgery
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-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
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Day of surgery
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Number of Participants Who Experienced Perioperative Complications
Time Frame: Day of surgery
|
-Complications experienced during surgery will be reviewed including:
|
Day of surgery
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Number of Participants Who Experienced Postoperative Complications
Time Frame: Up to 90 days postoperatively
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-Complications experienced after surgery will be reviewed including:
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Up to 90 days postoperatively
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Pancreatic Neoplasms
- Carcinoma, Ductal
Other Study ID Numbers
- 201311146
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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