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NCT Number: NCT01971775

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

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 82, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonically activated Shears

Device

Dissection and lymphovascular sealing with Ultrasonically Activated Shears

Other names: Harmonic Scalpel, Ethicon Endo-Surgery, INC (USA)

Conventional Monopolar Electrocautery

Device

Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Other names: Monopolar Electrocautery

Primary outcomes

  1. Intraoperative blood loss

    Time frame: within a month

  2. Amount of drain at postoperative period

    Time frame: within a month

Secondary outcomes

  1. Operation time

    Time frame: within 2 months

  2. Transfusion

    Time frame: within 2 months

  3. Inflammatory factors (Serum C-Reactive Protein and cytokines, ascites cytokines)

    Time frame: within 2 months

  4. Postoperative hospital stay

    Time frame: within 2 months

  5. 4. Postoperative hospital stay Complications

    Time frame: within 2 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Johnson & Johnson Medical Companies

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
First posted
Oct 29, 2013
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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