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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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

Keimyung University Dongsan Medical Center

Collaborators

Chonnam National University Hospital
Dong-A University Hospital

Investigators

  • 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

August 1, 2015

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

December 24, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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