Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

May 31, 2017 updated by: Seung Wan Ryu, Keimyung University Dongsan Medical Center

The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)

Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Seung Wan Ryu, M.D., Ph.D.
  • Phone Number: 82-53-250-7322
  • Email: gsman@dsmc.or.kr

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Recruiting
        • Dong-A University Hospital
        • Contact:
          • Min Chan Kim, MD, PhD
        • Principal Investigator:
          • Min Chan Kim, MD, PhD
      • Daegu, Korea, Republic of, 700-712
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seung Wan Ryu, MD, PhD
        • Sub-Investigator:
          • In Gyu Kwon, MD
        • Sub-Investigator:
          • Young Gil Son, MD, PhD
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 519-809
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
          • Young Kyu Park, MD, PhD
        • Sub-Investigator:
          • Seong Yeop Ryu, MD, PhD
        • Sub-Investigator:
          • Jeong Oh, MD, PhD
        • Sub-Investigator:
          • Mi Ran Jung, MD, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma in stomach
  • Aged≥20 years and ≤80 years
  • Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)
  • Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria
  • ECOG 0 (Eastern Cooperative Oncology Group)
  • ASA score class I-III (American Society of Anesthesiologists)
  • patient has given their written informed consent to participate in the study

Exclusion Criteria:

  • Simultaneously combined resection of other organ
  • Active other malignancy
  • Expected to severe intra-abdominal adhesion due to previous abdominal operation history
  • Uncontrolled co-morbidity
  • Vulnerable patients

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Omentum preserving
Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.
Procedure: Omentum preserving
The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
Experimental: Total omentectomy
Total omentectomy: Whole omentum will be removed.
Procedure: Total omentectomy
Whole omentum will be removed during gastrectomy with lymph node dissection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HOMA-IR change
Time Frame: pre-operative and post-operative 12months
HOMA-IR change after operation
pre-operative and post-operative 12months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
prevalence of metabolic syndrome
Time Frame: pre-operative and post-operative 12months
check the presence of metabolic syndrome
pre-operative and post-operative 12months
Complication
Time Frame: within 30days
short-term any complication related to surgery
within 30days
HOMA-IR change according to anastomosis type
Time Frame: pre-operative and post-operative 12months
comparison between Billoth-II and Roux-en-Y
pre-operative and post-operative 12months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Keimyung University Dongsan Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chonnam National University Hospital
Dong-A University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung Wan Ryu, M.D., Ph.D., Korean South West East Gastric Surgery Group

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-07-010
  • KSWEET-02 (Other Identifier: Korean South West East Gastric Surgery Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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