Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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

Official Title
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Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer: Conventional Monopolar Electrosurgery vs. Ultrasonically Activated Shear(UAS)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Device: Ultrasonically activated Shears
* Device: Conventional Monopolar Electrocautery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasonically Activated Shear<br>Dissection and lymphovascular sealing with Ultrasonically Activated Shears | Device: Ultrasonically activated Shears<br>* Dissection and lymphovascular sealing with Ultrasonically Activated Shears<br>* Other names: Harmonic Scalpel, Ethicon Endo-Surgery, INC (USA);|
| Active Comparator: Conventional Monopolar Electrocautery<br>Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery | Device: Conventional Monopolar Electrocautery<br>* Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery<br>* Other names: Monopolar Electrocautery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss |  | within a month | 
| Amount of drain at postoperative period |  | within a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time |  | within 2 months | 
| Transfusion |  | within 2 months | 
| Inflammatory factors (Serum C-Reactive Protein and cytokines, ascites cytokines) |  | within 2 months | 
| Postoperative hospital stay |  | within 2 months | 
| 4. Postoperative hospital stay Complications |  | within 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonically Activated Shear, Conventional Monopolar Electrocautery, Gastric Cancer