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Clinical Trials/NCT01714622
NCT01714622
Withdrawn
Not Applicable

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

Yonsei University3 sites in 1 countryOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer With Metabolic Syndrome or Metabolic Disease
Sponsor
Yonsei University
Locations
3
Primary Endpoint
the changes of metabolic syndrome
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • gastric cancer,
  • in plan for gastrectomy for gastric cancer
  • ages between 20 to 85 years old
  • assign in consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

the changes of metabolic syndrome

Time Frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy

Secondary Outcomes

  • the changes of insulin resistance after gastrectomy(baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy)

Study Sites (3)

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