Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastric Cancer With 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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- the changes of metabolic syndrome [ Time Frame: baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
in plan to underwent curative gastrectomy for gastric cancer
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.
Contacts and Locations| Contact: Ji Yeong An, MD | 82-2-2228-2095 | ugids@naver.com |
| Korea, Republic of | |
| Ji Yeong An | Not yet recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Ji Yeong An, MD | |
| Department of Surgery, Yonsei University Colleage of Medicine, | Not yet recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Ji Yeong An, MD 82-2-2228-2095 ugids@naver.com | |
| Sevrance hospital, Department of General surgery | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Ji Young An, MD 82 2 2228 2095 ajy8339@yuhs.ac | |
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01714622 History of Changes |
| Other Study ID Numbers: | 4-2012-0550 |
| Study First Received: | October 17, 2012 |
| Last Updated: | January 13, 2013 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Yonsei University:
|
metabolic syndrome insulin resistance gastric cancer |
Additional relevant MeSH terms:
|
Metabolic Diseases Glucose Metabolism Disorders Insulin Resistance Stomach Neoplasms Metabolic Syndrome X Hyperinsulinism Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 22, 2013