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

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ultrasonically activated Shears

Conventional Monopolar Electrocautery

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Ultrasonically Activated Shear, Conventional Monopolar Electrocautery, Gastric Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ultrasonically Activated Shear

Conventional Monopolar Electrocautery

Arm Description

Dissection and lymphovascular sealing with Ultrasonically Activated Shears

Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Outcomes

Primary Outcome Measures

Intraoperative blood loss

Amount of drain at postoperative period

Secondary Outcome Measures

Operation time

Transfusion

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

Postoperative hospital stay

4. Postoperative hospital stay Complications

Full Information

NCT ID

NCT01971775

First Posted

September 18, 2011

Last Updated

October 23, 2013

Sponsor

Seoul National University Hospital

Collaborators

Johnson & Johnson Medical Companies

1. Study Identification

Unique Protocol Identification Number

NCT01971775

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Johnson & Johnson Medical Companies

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Ultrasonically Activated Shear, Conventional Monopolar Electrocautery, Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasonically Activated Shear

Arm Type

Active Comparator

Arm Description

Dissection and lymphovascular sealing with Ultrasonically Activated Shears

Arm Title

Conventional Monopolar Electrocautery

Arm Type

Active Comparator

Arm Description

Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Intervention Type

Device

Intervention Name(s)

Ultrasonically activated Shears

Other Intervention Name(s)

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

Intervention Description

Dissection and lymphovascular sealing with Ultrasonically Activated Shears

Intervention Type

Device

Intervention Name(s)

Conventional Monopolar Electrocautery

Other Intervention Name(s)

Monopolar Electrocautery

Intervention Description

Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery

Primary Outcome Measure Information:

Title

Intraoperative blood loss

Time Frame

within a month

Title

Amount of drain at postoperative period

Time Frame

within a month

Secondary Outcome Measure Information:

Title

Operation time

Time Frame

within 2 months

Title

Transfusion

Time Frame

within 2 months

Title

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

Time Frame

within 2 months

Title

Postoperative hospital stay

Time Frame

within 2 months

Title

4. Postoperative hospital stay Complications

Time Frame

within 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Han-Kwang Yang, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital, Seoul, Korea, Republic of.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

27613551

Citation

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.

Results Reference

derived

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

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