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Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients

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ClinicalTrials.gov Identifier: NCT01643811
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Keun Won Ryu, National Cancer Center, Korea

Brief Summary:
The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.

Condition or disease Intervention/treatment
Early Gastric Cancer Procedure: gastrectomy Procedure: Endoscopic submucosal dissection

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Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
Study Start Date : April 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Gastrectomy
Patients who underwent gastrectomy for early gastric cancer
Procedure: gastrectomy
subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy

Endoscopic submucosal dissection
Patients who underwent endoscopic submucosal dissection for early gastric cancer
Procedure: Endoscopic submucosal dissection
endoscopic submucosal dissection




Primary Outcome Measures :
  1. Proportion of patients who quit previous medication for diabetes because of improved disease [ Time Frame: 5 year after operation ]
    proportion of patients who quit their previous medication for diabetes because of improved disease after operation among all patients who underwent gastrectomy for early gastric cancer with diabetes.

  2. Proportion of patients who quit previous medication for hypertension because of improved disease [ Time Frame: 5 years after operation ]
    Proportion of patients who quit previous medication for hypertension because of improved disease among the patients who diagnosed as early gastric cancer and hypertension


Secondary Outcome Measures :
  1. difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy [ Time Frame: 5 years after operation ]
    difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy

  2. difference of proportion of patients who quit previous medication for diabetes according to anastomosis [ Time Frame: 5 year after operation ]
    difference of proportion of patients who quit previous medication for diabetes among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy

  3. difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy [ Time Frame: 5 years after operation ]
    difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy

  4. difference of proportion of patients who quit previous medication for hypertension according to anastomosis [ Time Frame: 5 years after operation ]
    difference of proportion of patients who quit previous medication for hypertension among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy

  5. difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation [ Time Frame: 1 years after operation ]
    difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation in patients with diabetes



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients diagnosed as early gastric cancer
Criteria

Inclusion Criteria:

  • Histologically proven primary gastric adenocarcinoma
  • clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed tomography
  • aged 20-80 year old,
  • performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • diagnosed as diabetes or hypertension
  • patients planning to undergo gastrectomy or endoscopic submucosal dissection
  • written informed consent

Exclusion Criteria:

  • having high risk for operation such as severe heart disease, severe respiratory disease
  • pregnant
  • previous abdominal surgery or radiation therapy
  • proven more advanced disease than pathological stage II requiring adjuvant chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643811


Locations
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Korea, Republic of
National Cancer Center
Goyang, Kyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
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Responsible Party: Keun Won Ryu, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01643811    
Other Study ID Numbers: 1210552-1
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Keywords provided by Keun Won Ryu, National Cancer Center, Korea:
early gastric cancer, diabetes, hypertension
Additional relevant MeSH terms:
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Stomach Neoplasms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases