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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971775
• Other study ID #: ENERGY_FRM001480
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2011
• Last updated: October 23, 2013
• Start date: August 2011

Study information

• Verified date: October 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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,

1. Evaluate the utility, efficacy, and safety of energy based device, in the case of open gastrectomy

2. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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:

1. Previous abdominal operation Hx.

2. Patients who are impossible to undergo Billroth-I reconstruction because of duodenal invasion caused by duodenal ulcers or gastric cancer

3. Patients who have CT defined ascites prior to operation

4. Patients with liver dysfunction defined as T.Bil>1.2 or albumin<3.0

5. 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

6. Patients with renal dysfunction defined as creatinine>1.4 mg/dL or Blood Urea Nitrogen>26mg/dL

7. Patients with severe pulmonary dysfunction defined as Forced Expiratory Volume at 1 second<1.0 L in Pulmonary Function Test

8. Patients with abnormal coagulation (PT International Normalized Ratio >1.2 or activated Partial Thromboplastin Time>45 sec)

9. Patients with uncontrolled diabetes

10. Treatment with aspirin or antithrombotic agents within 7days before operation

11. Treatment with anticoagulant drug

12. History of preoperative stress dose steroid treatment

13. Patients who the investigators believe will be ineligible for participation in the clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• Ultrasonically activated Shears
Dissection and lymphovascular sealing with Ultrasonically Activated Shears
• Conventional Monopolar Electrocautery
Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Johnson & Johnson Medical Companies

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss		within a month	No
Primary	Amount of drain at postoperative period		within a month	No
Secondary	Operation time		within 2 months	No
Secondary	Transfusion		within 2 months	No
Secondary	Inflammatory factors (Serum C-Reactive Protein and cytokines, ascites cytokines)		within 2 months	No
Secondary	Postoperative hospital stay		within 2 months	No
Secondary	4. Postoperative hospital stay Complications		within 2 months	Yes