Clinical Study for Energy Based Devices in Open Gastrectomy for Gastric Cancer
1 other identifier
interventional
56
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 29, 2013
CompletedOctober 29, 2013
October 1, 2013
1.8 years
September 18, 2011
October 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intraoperative blood loss
within a month
Amount of drain at postoperative period
within a month
Secondary Outcomes (5)
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
Study Arms (2)
Ultrasonically Activated Shear
ACTIVE COMPARATORDissection and lymphovascular sealing with Ultrasonically Activated Shears
Conventional Monopolar Electrocautery
ACTIVE COMPARATORDissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Interventions
Dissection and lymphovascular sealing with Ultrasonically Activated Shears
Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
Eligibility Criteria
You may qualify if:
- 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
- ≤ age ≤ 75
- Patients with informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 82, South Korea
Related Publications (1)
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.
PMID: 27613551DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Kwang Yang, M.D., Ph.D.
Seoul National University Hospital, Seoul, Korea, Republic of.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2011
First Posted
October 29, 2013
Study Start
August 1, 2011
Primary Completion
May 1, 2013
Last Updated
October 29, 2013
Record last verified: 2013-10