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

Sponsor

Yonsei University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01714622

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

the changes of metabolic syndrome [baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Department of Surgery, Yonsei University Colleage of Medicine,	Seoul	Korea, Republic of	120-752
2	Ji Yeong An	Seoul	Korea, Republic of	120-752
3	Sevrance hospital, Department of General surgery	Seoul	Korea, Republic of	120-752