Whipple Procedure: Standard of Care vs. Thunderbeat

Not Applicable

Terminated

Conditions: Bile Duct Carcinoma
Pancreatic Neoplasms

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

Registration Number: NCT02204124

Lead Sponsor: Washington University School of Medicine

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 44

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 Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thunderbeat™	Thunderbeat	-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
Control Group	Standard of care scissors, ligatures, clips, and sutures	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.

Primary Outcome Measures

Name	Time	Method
Post-op Morbidity	Up to 90 days postoperatively	-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.
Operative Blood Loss	Day of surgery	* 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.

Secondary Outcome Measures

Name	Time	Method
Cost Using Thunderbeat Device	Up to 90 days postoperatively	-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively
Number of Participants Who Experienced Postoperative Complications	Up to 90 days postoperatively	-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
Operative Time	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).
Anesthesia Time	Day of surgery	-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
Number of Participants Who Experienced Perioperative Complications	Day of surgery	-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

Trial Locations

Locations (1): Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States

Whipple Procedure: Standard of Care vs. Thunderbeat

Recruitment & Eligibility

Study & Design

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