Whipple Procedure: Standard of Care vs. Thunderbeat

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02204124
• Other study ID #: 201311146
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: August 23, 2017

Study information

• Verified date: August 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: August 23, 2017
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Carcinoma
• Carcinoma, Ductal
• Pancreatic Neoplasms

Intervention

Device:
• Thunderbeat
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
• Standard of care scissors, ligatures, clips, and sutures

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Anesthesia Time	-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation	Day of surgery
Secondary	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
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine