Gastric Cancer With Metabolic Syndrome or Metabolic Disease Clinical Trial
| NCT number | NCT01714622 |
| Other study ID # | 4-2012-0550 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2012 |
| Est. completion date | October 2016 |
| Verified date | September 2015 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Surgery, Yonsei University Colleage of Medicine, | Seoul | |
| Korea, Republic of | Ji Yeong An | Seoul | |
| Korea, Republic of | Sevrance hospital, Department of General surgery | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the changes of metabolic syndrome | baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy | ||
| Secondary | the changes of insulin resistance after gastrectomy | baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy |