Whipple Procedure: Standard of Care vs. Thunderbeat

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02204124
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms; Bile Duct Carcinoma	Device: Thunderbeat; Device: Standard of care scissors, ligatures, clips, and sutures	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: The participants will be blinded to the assigned operating technique.
• Primary Purpose: Treatment
• Official Title: Thunderbeat™ Integrated Bipolar and Ultrasonic Forceps in the Whipple Procedure: A Prospective Registry Trial
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Aug 23, 2017
• Actual Study Completion Date: Aug 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group 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
Experimental: Thunderbeat™ -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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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).

2. 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

3. Anesthesia Time [Day of surgery]

   -Anesthesia time measured from the initiation of anesthesia induction to the time of extubation

4. 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

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: William Hawkins, M.D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 14, 2015

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02204124
• Other Study ID Numbers: 201311146
• First Posted: Jul 30, 2014
• Last Update Posted: Sep 19, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Washington University School of Medicine: Whipple procedure
• Additional relevant MeSH terms: Pancreatic Neoplasms; Carcinoma, Ductal

Study Results

Participant Flow

Recruitment Details	The study opened to participant enrollment on 01/01/2015 and closed to participant enrollment on 08/09/2017.
Pre-assignment Detail	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.

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Period Title: Overall Study
STARTED	13	19
COMPLETED	13	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Thunderbeat™	Total
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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 of all reporting groups
Overall Participants	13	19	32
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.6 (11.9)	64.8 (11.3)	64.7 (11.4)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	5 26.3%	11 34.4%
Male	7 53.8%	14 73.7%	21 65.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	13 100%	19 100%	32 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 7.7%	0 0%	1 3.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 5.3%	1 3.1%
White	12 92.3%	18 94.7%	30 93.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	13 100%	19 100%	32 100%
Received Neoadjuvant Therapy (Count of Participants)
Count of Participants [Participants]	3 23.1%	5 26.3%	8 25%
Body Mass Index (BMI) > 30 kg/m^2 (Count of Participants)
Count of Participants [Participants]	2 15.4%	5 26.3%	7 21.9%

Outcome Measures

1. Primary Outcome

Title	Operative Blood Loss
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	13	19
Mean (Standard Deviation) [mL]	263.5 (190.0)	480.2 (300.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Post-op Morbidity
Description	-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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	13	19
Count of Participants [Participants]	7 53.8%	8 42.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.513
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Operative Time
Description	-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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	13	19
Median (Full Range) [minutes]	220	270

4. Secondary Outcome

Title	Cost Using Thunderbeat Device
Description	-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

Outcome Measure Data

Analysis Population Description

The data for this outcome measure was not collected.

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	0	0

5. Secondary Outcome

Title	Anesthesia Time
Description	-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	13	19
Mean (Standard Deviation) [minutes]	282.7 (50.8)	357.3 (89.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Number of Participants Who Experienced Perioperative Complications
Description	-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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	13	19
Count of Participants [Participants]	0 0%	3 15.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.132
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Number of Participants Who Experienced Postoperative Complications
Description	-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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.	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.
Measure Participants	13	19
Readmission	2 15.4%	3 15.8%
Mortality	0 0%	0 0%
Bleeding/hematoma	0 0%	0 0%
Wound infection	0 0%	1 5.3%
Gastroparesis	2 15.4%	3 15.8%
Pancreatic fistula	0 0%	1 5.3%
Intraabdominal abscess	0 0%	1 5.3%
Anastomotic leakage	0 0%	1 5.3%
Blood product transfusion (anemia)	1 7.7%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #1 is for readmission
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.975
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #2 is for wound infection.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.401
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #3 is for gastroparesis.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.975
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #4 is for pancreatic fistula.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.401
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #5 is for intraabdominal abscess.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.219
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #6 is for anastomotic leakage.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.401
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Control Group, Thunderbeat™
	Comments	Statistical analysis #7 is for blood product transfusion (anemia).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.219
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	-Adverse events were collected from the time of surgery through 90 days following completion of surgery.
Adverse Event Reporting Description	-Surgical complications will not be considered adverse events associated with the study, unless unanticipated and possibly related to the use of the Thunderbeat device.
Arm/Group Title	Control Group		Thunderbeat™
Arm/Group Description	In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary.		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.
All Cause Mortality
	Control Group		Thunderbeat™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/19 (0%)
Serious Adverse Events
	Control Group		Thunderbeat™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Thunderbeat™
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.