Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer
Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer: Conventional Monopolar Electrosurgery vs. Ultrasonically Activated Shear(UAS)
Surgery is the first standard treatment for stomach cancer, but it still has negative factors such as bleeding, leakage, closure, surgery part infection and cardiovascular and lung complication by general anesthesia.
electric cautery is used extensively in surgery room due to the utility of simultaneous severance and hemostasis. In some case, the electric current from vitality electrode may unexpectedly stimulate or damage nearby muscles and nerves. Ultrasonically activated shears (UAS) is a device to transform the protein of organ for organ incision or hemostasis. General advantages possibly include shortened operating time, decrease of operative blood loss, and relatively less damages to the normal organ. UAS is commonly used in the operation room, which is now considered as a secure and useful medical device for for tissue dissection and coagulation. Also, it is expected to lower the risk of surgery by reducing operating time and blood loss.
However, clinical evidence is not sufficient for this device until now. Therefore, in this study,
- Evaluate the utility, efficacy, and safety of energy based device, in the case of open gastrectomy
- Would like to compare the following two kinds of energy based devices. A. For conventional monopolar electrosurgery group : dissection and sealing will be conducted by conventional monopolar electrocautery device B. For UAS group : dissection and sealing will be conducted by UAS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 82
- Seoul National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically proven primary gastric adenocarcinoma
- Patients who may undergo distal gastrectomy
- Patients who qualified for open gastrectomy for gastric cancer stage T1-3, M0 according to the 7th International Union Against Cancer classification
- 20 ≤ age ≤ 75
- Patients with informed consent
Exclusion Criteria:
- Previous abdominal operation Hx.
- Patients who are impossible to undergo Billroth-I reconstruction because of duodenal invasion caused by duodenal ulcers or gastric cancer
- Patients who have CT defined ascites prior to operation
- Patients with liver dysfunction defined as T.Bil>1.2 or albumin<3.0
- Patients with heart disease such as uncontrolled hypertension, history of angina or coronary artery disease, history of cardiomyopathy, Ventricular Ejection Fraction <50% measured by echocardiography
- Patients with renal dysfunction defined as creatinine>1.4 mg/dL or Blood Urea Nitrogen>26mg/dL
- Patients with severe pulmonary dysfunction defined as Forced Expiratory Volume at 1 second<1.0 L in Pulmonary Function Test
- Patients with abnormal coagulation (PT International Normalized Ratio >1.2 or activated Partial Thromboplastin Time>45 sec)
- Patients with uncontrolled diabetes
- Treatment with aspirin or antithrombotic agents within 7days before operation
- Treatment with anticoagulant drug
- History of preoperative stress dose steroid treatment
- Patients who the investigators believe will be ineligible for participation in the clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultrasonically Activated Shear
Dissection and lymphovascular sealing with Ultrasonically Activated Shears
|
Dissection and lymphovascular sealing with Ultrasonically Activated Shears
Other Names:
|
|
Active Comparator: Conventional Monopolar Electrocautery
Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
|
Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intraoperative blood loss
Time Frame: within a month
|
within a month
|
|
Amount of drain at postoperative period
Time Frame: within a month
|
within a month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Operation time
Time Frame: within 2 months
|
within 2 months
|
|
Transfusion
Time Frame: within 2 months
|
within 2 months
|
|
Inflammatory factors (Serum C-Reactive Protein and cytokines, ascites cytokines)
Time Frame: within 2 months
|
within 2 months
|
|
Postoperative hospital stay
Time Frame: within 2 months
|
within 2 months
|
|
4. Postoperative hospital stay Complications
Time Frame: within 2 months
|
within 2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Han-Kwang Yang, M.D., Ph.D., Seoul National University Hospital, Seoul, Korea, Republic of.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENERGY_FRM001480
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