Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance

March 27, 2019 updated by: Yonsei University

Gastric cancer is still one of the most common malignance in Korea. Because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. In this reason, the interest of outcomes after gastrectomy for gastric cancer move survival only to quality of life of these patients.

Although the definition of metabolic syndrome is various, but it is normally accepted as a state that insulin resistance or glucose intolerance combined with hypertension or hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the treatment is modification of life style, weight loss and medication. However, in most of the patients metabolic syndrome is considered not curable disease. Recent studies have shown that some bariatric surgery offers not only control the overweight but also metabolic syndrome. The exact mechanism is still unknown but decreased gastric volume and intestinal bypass itself seemed to play an important role to improve metabolic syndrome over just decreased weight.

For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy, esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this operation could lead similar effect of bariatric surgery. Already, there have been several retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no prospective study about this subject yet in Korea.

The purpose of this study is that evaluating the degree of improvement of metabolic syndrome after gastrectomy for gastric cancer, and analyze the differences between the type of operation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Surgery, Yonsei University Colleage of Medicine,
      • Seoul, Korea, Republic of, 120-752
        • Ji Yeong An
      • Seoul, Korea, Republic of, 120-752
        • Sevrance hospital, Department of General surgery

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

Sampling Method

Non-Probability Sample

Study Population

in plan to underwent curative gastrectomy for gastric cancer

Description

Inclusion Criteria:

  1. gastric cancer,
  2. in plan for gastrectomy for gastric cancer
  3. ages between 20 to 85 years old
  4. assign in consent

Exclusion Criteria:

  1. vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical students)
  2. had low performance scale due to severe cardiovascular disease.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
metabolic syndrome
gastric cancer patients with metabolic syndrome
Procedure: subtotal gastrectomy with gastroduodenostomy
Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,
Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy
metabolic disease
gastric cancer patients with metabolic disease
Procedure: subtotal gastrectomy with gastroduodenostomy
Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,
Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy
normal
gastric cancer patients without metabolic syndrome or metabolic disease
Procedure: subtotal gastrectomy with gastroduodenostomy
Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,
Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the changes of metabolic syndrome
Time Frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
the changes of insulin resistance after gastrectomy
Time Frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy

Collaborators and Investigators

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

Sponsor

Yonsei University

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

October 1, 2012

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0550

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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