Whipple Procedure: Standard of Care vs. Thunderbeat

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial

Conditions
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Pancreatic Neoplasms, Bile Duct Carcinoma

Intervention / Treatment
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* Device: Thunderbeat
* Device: Standard of care scissors, ligatures, clips, and sutures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br> <br> |
| Experimental: Thunderbeat™<br>-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan). | Device: Thunderbeat<br>* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | -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 | 
| Cost Using Thunderbeat Device | -Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively | Up to 90 days postoperatively | 
| Anesthesia Time | -Anesthesia time measured from the initiation of anesthesia induction to the time of extubation | Day of surgery | 
| Number of Participants Who Experienced Perioperative Complications | -Complications experienced during surgery will be reviewed including: Iatrogenic injury need for conversion from laparoscopic approach to open procedure need for the use of other hemostatic devices or therapies intraoperative requirement of blood product transfusion | Day of surgery | 
| Number of Participants Who Experienced Postoperative Complications | -Complications experienced after surgery will be reviewed including: secondary bleeding/hematoma wound infection gastroparesis postoperative pancreatic fistula intraabdominal abscess anastomotic leakage re-intervention (operational) postop requirement for blood product transfusion hospital mortality | Up to 90 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whipple procedure