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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 11, 2012
First Posted Date July 18, 2012
Last Update Posted Date March 24, 2016
Study Start Date April 2012
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 4, 2013)
  • 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.
  • 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
Original Primary Outcome Measures
 (submitted: July 16, 2012)
  • Proportion of patients who quit previous medication for diabetis 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.
  • 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
Change History
Current Secondary Outcome Measures
 (submitted: March 4, 2013)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: July 16, 2012)
  • 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
  • difference of proportion of patients who quit previous medication for diabetes between patients who underwent gastroduodenostomy and those who underwent gastrojejunostomy [ Time Frame: 5 year after operation ]
    difference of proportion of patients who quit previous medication for diabetes between patients who underwent gastroduodenostomy and those who underwent gastrojejunostomy
  • 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
  • difference of proportion of patients who quit previous medication for hypertension between patients who underwent gastroduodenostomy and those who underwent gastrojejunostomy [ Time Frame: 5 years after operation ]
    difference of proportion of patients who quit previous medication for hypertension between patients who underwent gastroduodenostomy and those who underwent gastrojejunostomy
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients
Official Title Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients diagnosed as early gastric cancer
Condition Early Gastric Cancer
Intervention
  • Procedure: gastrectomy
    subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy
  • Procedure: Endoscopic submucosal dissection
    endoscopic submucosal dissection
Study Groups/Cohorts
  • Gastrectomy
    Patients who underwent gastrectomy for early gastric cancer
    Intervention: Procedure: gastrectomy
  • Endoscopic submucosal dissection
    Patients who underwent endoscopic submucosal dissection for early gastric cancer
    Intervention: Procedure: Endoscopic submucosal dissection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2015)
159
Original Estimated Enrollment
 (submitted: July 16, 2012)
120
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01643811
Other Study ID Numbers 1210552-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Keun Won Ryu, National Cancer Center, Korea
Study Sponsor National Cancer Center, Korea
Collaborators Not Provided
Investigators Not Provided
PRS Account National Cancer Center, Korea
Verification Date March 2016