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Gastric CancerPhase 3NCT01971775

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

A Phase 3 study testing Ultrasonically activated Shears and Conventional Monopolar Electrocautery in people with Gastric Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Ultrasonically activated Shears and Conventional Monopolar Electrocautery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSouth Korea
Study dates
Aug 2011to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 82

Other trials in South Korea

About this study

Official title: 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.

Read more

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
Conditions
Gastric Cancer
Being tested
Ultrasonically activated Shears, Conventional Monopolar Electrocautery
Keywords
Ultrasonically Activated Shear, Conventional Monopolar Electrocautery, Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasonically activated ShearsDevice

    Also called Harmonic Scalpel, Ethicon Endo-Surgery, INC (USA)

    Dissection and lymphovascular sealing with Ultrasonically Activated Shears

  • Conventional Monopolar ElectrocauteryDevice

    Also called Monopolar Electrocautery

    Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Study groups in NCT01971775
Study groupRoleWhat they receive
Ultrasonically Activated ShearActive comparatorDissection and lymphovascular sealing with Ultrasonically Activated Shears
Receives: Device: Ultrasonically activated Shears
Conventional Monopolar ElectrocauteryActive comparatorDissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Receives: Device: Conventional Monopolar Electrocautery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative blood loss

    Measured: within a month

  2. Amount of drain at postoperative period

    Measured: within a month

Secondary outcomes (5)

  1. Operation time

    Measured: within 2 months

  2. Transfusion

    Measured: within 2 months

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

    Measured: within 2 months

  4. Postoperative hospital stay

    Measured: within 2 months

  5. 4. Postoperative hospital stay Complications

    Measured: within 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01971775
Sponsor's protocol ID
ENERGY_FRM001480
Status last verified
Oct 2013
First submitted
18 Sep 2011
Last updated
29 Oct 2013
Results posted
No

Publications

  • Oh SY, Choi B, Lee KG, Choe HN, Lee HJ, Suh YS, Kong SH, Lee HJ, Kim WH, Yang HK. Ultrasonically Activated Shears Reduce Blood Loss without Increasing Inflammatory Reactions in Open Distal Gastrectomy for Cancer: A Randomized Controlled Study. Ann Surg Oncol. 2017 Feb;24(2):494-501. doi: 10.1245/s10434-016-5518-3. Epub 2016 Sep 9.

    PubMed 27613551

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ultrasonically activated Shears and Conventional Monopolar Electrocautery in people with Gastric Cancer, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative blood loss (time frame: within a month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01971775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013; AzTrials last refreshed its copy on 3 Nov 2026.

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