Clinical trial NCT01714622: Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastric Cancer With Metabolic Syndrome or Metabolic Disease
Keywords: metabolic syndrome
insulin resistance
gastric cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in plan to underwent curative gastrectomy for gastric cancer

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the changes of metabolic syndrome
timeFrame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
Secondary outcomes:
measure: the changes of insulin resistance after gastrectomy
timeFrame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University Colleage of Medicine,
city: Seoul
country: Korea, Republic of
facility: Ji Yeong An
city: Seoul
country: Korea, Republic of
facility: Sevrance hospital, Department of General surgery
Study officials:
References: