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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01714622
First received: October 17, 2012
Last updated: February 17, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
in plan to underwent curative gastrectomy for gastric cancer
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714622

Locations
Korea, Republic of
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
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

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: February 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
metabolic syndrome
insulin resistance
gastric cancer

Additional relevant MeSH terms:
Syndrome
Stomach Neoplasms
Metabolic Syndrome X
Insulin Resistance
Metabolic Diseases
Disease
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on December 07, 2016