An interventional study of Thunderbeat and Standard of care scissors, ligatures, clips, and sutures in Pancreatic Neoplasms and Bile Duct Carcinoma, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-19.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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
-In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
Device: Thunderbeat
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
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.
Time frame: 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.
Time frame: Up to 90 days postoperatively
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).
Time frame: 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
Time frame: Up to 90 days postoperatively
Anesthesia Time
-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
Time frame: 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
Time frame: 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
Time frame: Up to 90 days postoperatively
The study opened to participant enrollment on 01/01/2015 and closed to participant enrollment on 08/09/2017.
| Milestone | Control Group | Thunderbeat™ |
|---|---|---|
| Started | 13 | 19 |
| Completed | 13 | 19 |
| Not completed | 0 | 0 |
* 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.
| mL | Control Group | Thunderbeat™ |
|---|---|---|
| Operative Blood Loss | 263.5 ± 190.0 | 480.2 ± 300.5 |
-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.
| Participants | Control Group | Thunderbeat™ |
|---|---|---|
| Post-op Morbidity | 7 | 8 |
-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).
| minutes | Control Group | Thunderbeat™ |
|---|---|---|
| Operative Time | 220 (143 to 296) | 270 (183 to 491) |
-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively
No measurements were reported for this outcome.
-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
| minutes | Control Group | Thunderbeat™ |
|---|---|---|
| Anesthesia Time | 282.7 ± 50.8 | 357.3 ± 89.2 |
-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
| Participants | Control Group | Thunderbeat™ |
|---|---|---|
| Number of Participants Who Experienced Perioperative Complications | 0 | 3 |
-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
| Participants | Control Group | Thunderbeat™ |
|---|---|---|
| Readmission | 2 | 3 |
| Mortality | 0 | 0 |
| Bleeding/hematoma | 0 | 0 |
| Wound infection | 0 | 1 |
| Gastroparesis | 2 | 3 |
| Pancreatic fistula | 0 | 1 |
| Intraabdominal abscess | 0 | 1 |
| Anastomotic leakage | 0 | 1 |
| Blood product transfusion (anemia) | 1 | 0 |
Collected over -Adverse events were collected from the time of surgery through 90 days following completion of surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Thunderbeat™ | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| Mean | 64.6 ± 11.9 | 64.8 ± 11.3 | 64.7 ± 11.4 |
| Sex: Female, Male(Participants) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 7 | 14 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 19 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 12 | 18 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| United States | 13 | 19 | 32 |
| Received Neoadjuvant Therapy(Participants) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| Count of participants | 3 | 5 | 8 |
| Body Mass Index (BMI) > 30 kg/m^2(Participants) | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| Count of participants | 2 | 5 | 7 |
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Washington University School of Medicine