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

October 23, 2013 updated by: Seoul National University Hospital

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,

  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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: Ultrasonically activated Shears
Dissection and lymphovascular sealing with Ultrasonically Activated Shears
Other Names:
  • Harmonic Scalpel, Ethicon Endo-Surgery, INC (USA)
Active Comparator: Conventional Monopolar Electrocautery
Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Device: Conventional Monopolar Electrocautery
Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Other Names:
  • Monopolar Electrocautery

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

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Johnson & Johnson Medical Companies

Investigators

  • Principal Investigator: Han-Kwang Yang, M.D., Ph.D., Seoul National University Hospital, Seoul, Korea, Republic of.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 18, 2011

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENERGY_FRM001480

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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