Clinical trial NCT02204124: Whipple Procedure: Standard of Care vs. Thunderbeat
Official title: Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Neoplasms
Bile Duct Carcinoma
Keywords: Whipple procedure
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Operative Blood Loss
timeFrame: Day of surgery
measure: Post-op Morbidity
timeFrame: Up to 90 days postoperatively
Secondary outcomes:
measure: Operative Time
timeFrame: Day of surgery
measure: Cost Using Thunderbeat Device
timeFrame: Up to 90 days postoperatively
measure: Anesthesia Time
timeFrame: Day of surgery
measure: Number of Participants Who Experienced Perioperative Complications
timeFrame: Day of surgery
measure: Number of Participants Who Experienced Postoperative Complications
timeFrame: Up to 90 days postoperatively
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: William Hawkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: