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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastric Cancer With Metabolic Syndrome or Metabolic Disease
• Intervention / Treatment: Procedure: subtotal gastrectomy with gastroduodenostomy; Procedure: subtotal gastrectomy with Roux-en-Y gastrojejunostomy,; Procedure: total gastrectomy with Rou-en-Y esophagojejunostomy

• Study Type: Observational

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Surgery, Yonsei University Colleage of Medicine,
  • Seoul, Korea, Republic of, 120-752
    • Ji Yeong An
  • Seoul, Korea, Republic of, 120-752
    • Sevrance hospital, Department of General surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

in plan to underwent curative gastrectomy for gastric cancer

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
the changes of insulin resistance after gastrectomy	baseline to postoperative 3 month, and there after every 6 months until 24 months after the gastrectomy

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: insulin resistance; gastric cancer; metabolic syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Hyperinsulinism; Syndrome; Stomach Neoplasms; Metabolic Syndrome; Insulin Resistance; Metabolic Diseases
• Other Study ID Numbers: 4-2012-0550