Pancreatic Neoplasms, Bile Duct Carcinoma
Conditions
Keywords
Whipple procedure
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.
Interventions
DEVICEThunderbeat
Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
DEVICEStandard of care scissors, ligatures, clips, and sutures
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The participants will be blinded to the assigned operating technique.
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Anesthesia Time | Day of surgery | -Anesthesia time measured from the initiation of anesthesia induction to the time of extubation |
| 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). |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Group In the control group, scissors, ligatures, clips and sutures will be used for dissection and hemostasis as necessary. | 13 |
| 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. | 19 |
| Total | 32 |
Baseline characteristics
| Characteristic | Control Group | Thunderbeat™ | Total |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 11.9 | 64.8 years STANDARD_DEVIATION 11.3 | 64.7 years STANDARD_DEVIATION 11.4 |
| Body Mass Index (BMI) > 30 kg/m^2 | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 19 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 18 Participants | 30 Participants |
| Received Neoadjuvant Therapy | 3 Participants | 5 Participants | 8 Participants |
| Region of Enrollment United States | 13 Participants | 19 Participants | 32 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 19 |
| other Total, other adverse events | 0 / 13 | 0 / 19 |
| serious Total, serious adverse events | 0 / 13 | 0 / 19 |
Outcome results
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.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Operative Blood Loss | 263.5 mL | Standard Deviation 190 |
| Thunderbeat™ | Operative Blood Loss | 480.2 mL | Standard Deviation 300.5 |
p-value: 0.032Wilcoxon (Mann-Whitney)
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.
Time frame: Up to 90 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Post-op Morbidity | 7 Participants |
| Thunderbeat™ | Post-op Morbidity | 8 Participants |
p-value: 0.513Chi-squared
Secondary
Anesthesia Time
-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Anesthesia Time | 282.7 minutes | Standard Deviation 50.8 |
| Thunderbeat™ | Anesthesia Time | 357.3 minutes | Standard Deviation 89.2 |
p-value: 0.013Wilcoxon (Mann-Whitney)
Secondary
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
Population: The data for this outcome measure was not collected.
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
Time frame: Day of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants Who Experienced Perioperative Complications | 0 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Perioperative Complications | 3 Participants |
p-value: 0.132Chi-squared
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
Time frame: Up to 90 days postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Number of Participants Who Experienced Postoperative Complications | Blood product transfusion (anemia) | 1 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Readmission | 2 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Mortality | 0 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Bleeding/hematoma | 0 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Wound infection | 0 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Gastroparesis | 2 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Pancreatic fistula | 0 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Intraabdominal abscess | 0 Participants |
| Control Group | Number of Participants Who Experienced Postoperative Complications | Anastomotic leakage | 0 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Intraabdominal abscess | 1 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Gastroparesis | 3 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Readmission | 3 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Blood product transfusion (anemia) | 0 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Mortality | 0 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Pancreatic fistula | 1 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Bleeding/hematoma | 0 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Anastomotic leakage | 1 Participants |
| Thunderbeat™ | Number of Participants Who Experienced Postoperative Complications | Wound infection | 1 Participants |
Comparison: Statistical analysis #1 is for readmissionp-value: 0.975Chi-squared
Comparison: Statistical analysis #2 is for wound infection.p-value: 0.401Chi-squared
Comparison: Statistical analysis #3 is for gastroparesis.p-value: 0.975Chi-squared
Comparison: Statistical analysis #4 is for pancreatic fistula.p-value: 0.401Chi-squared
Comparison: Statistical analysis #5 is for intraabdominal abscess.p-value: 0.219Chi-squared
Comparison: Statistical analysis #6 is for anastomotic leakage.p-value: 0.401Chi-squared
Comparison: Statistical analysis #7 is for blood product transfusion (anemia).p-value: 0.219Chi-squared
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).
Time frame: Day of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Operative Time | 220 minutes |
| Thunderbeat™ | Operative Time | 270 minutes |