Whipple Procedure: Standard of Care vs. Thunderbeat
| Status: | Terminated |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - 75 |
| Updated: | 9/21/2018 |
| Start Date: | January 1, 2015 |
| End Date: | August 23, 2017 |
Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
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.
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.
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.
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.
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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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