Trial Outcomes & Findings for Whipple Procedure: Standard of Care vs. Thunderbeat (NCT NCT02204124)
NCT ID: NCT02204124
Last Updated: 2018-09-19
Results Overview
* 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.
TERMINATED
NA
44 participants
Day of surgery
2018-09-19
Participant Flow
The study opened to participant enrollment on 01/01/2015 and closed to participant enrollment on 08/09/2017.
There were 44 enrolled to the study. 12 were enrolled but were not randomized to an arm and did not start the study due to reasons such as ineligibility, physician discretion, and because the Thunderbeat was not in the operating room.
Participant milestones
| Measure |
Control Group
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
19
|
|
Overall Study
COMPLETED
|
13
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whipple Procedure: Standard of Care vs. Thunderbeat
Baseline characteristics by cohort
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Received Neoadjuvant Therapy
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Body Mass Index (BMI) > 30 kg/m^2
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Operative Blood Loss
|
263.5 mL
Standard Deviation 190.0
|
480.2 mL
Standard Deviation 300.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Post-op Morbidity
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Operative Time
|
220 minutes
Interval 143.0 to 296.0
|
270 minutes
Interval 183.0 to 491.0
|
SECONDARY outcome
Timeframe: Up to 90 days postoperativelyPopulation: The data for this outcome measure was not collected.
-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day of surgery-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
Outcome measures
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Anesthesia Time
|
282.7 minutes
Standard Deviation 50.8
|
357.3 minutes
Standard Deviation 89.2
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Number of Participants Who Experienced Perioperative Complications
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=13 Participants
In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.
|
Thunderbeat™
n=19 Participants
* In the Thunderbeat™ group, dissection and hemostasis of vessels will be performed using the Thunderbeat™ device (Olympus, Japan).
* Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
|
|---|---|---|
|
Number of Participants Who Experienced Postoperative Complications
Readmission
|
2 Participants
|
3 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Mortality
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Intraabdominal abscess
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Bleeding/hematoma
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Wound infection
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Gastroparesis
|
2 Participants
|
3 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Pancreatic fistula
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Anastomotic leakage
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Postoperative Complications
Blood product transfusion (anemia)
|
1 Participants
|
0 Participants
|
Adverse Events
Control Group
Thunderbeat™
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William Hawkins, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place