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

NCT ID: NCT01714622

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer With Metabolic Syndrome or Metabolic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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metabolic syndrome

gastric cancer patients with metabolic syndrome

subtotal gastrectomy with gastroduodenostomy

Intervention Type PROCEDURE

subtotal gastrectomy with Roux-en-Y gastrojejunostomy,

Intervention Type PROCEDURE

total gastrectomy with Rou-en-Y esophagojejunostomy

Intervention Type PROCEDURE

metabolic disease

gastric cancer patients with metabolic disease

subtotal gastrectomy with gastroduodenostomy

Intervention Type PROCEDURE

subtotal gastrectomy with Roux-en-Y gastrojejunostomy,

Intervention Type PROCEDURE

total gastrectomy with Rou-en-Y esophagojejunostomy

Intervention Type PROCEDURE

normal

gastric cancer patients without metabolic syndrome or metabolic disease

subtotal gastrectomy with gastroduodenostomy

Intervention Type PROCEDURE

subtotal gastrectomy with Roux-en-Y gastrojejunostomy,

Intervention Type PROCEDURE

total gastrectomy with Rou-en-Y esophagojejunostomy

Intervention Type PROCEDURE

Interventions

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subtotal gastrectomy with gastroduodenostomy

Intervention Type PROCEDURE

subtotal gastrectomy with Roux-en-Y gastrojejunostomy,

Intervention Type PROCEDURE

total gastrectomy with Rou-en-Y esophagojejunostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Surgery, Yonsei University Colleage of Medicine,

Seoul, , South Korea

Site Status

Ji Yeong An

Seoul, , South Korea

Site Status

Sevrance hospital, Department of General surgery

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2012-0550

Identifier Type: -

Identifier Source: org_study_id

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