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

This study is currently recruiting participants.
Verified March 2013 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Keun Won Ryu, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01643811
First received: July 11, 2012
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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 Intervention
Early Gastric Cancer
Procedure: gastrectomy
Procedure: Endoscopic submucosal dissection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Proportion of patients who quit previous medication for diabetes because of improved disease [ Time Frame: 5 year after operation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation in patients with diabetes


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643811

Contacts
Contact: Keun Won Ryu, PhD 82-31-920-1628 docryu@korea.com
Contact: Eun Kyung Lee 82-920-1743 waterfol@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Kyeonggi-do, Korea, Republic of, 410-769
Contact: Keun Won Ryu, PhD    82-31-920-1628    docryu@korea.com   
Contact: Eun Kyung Lee    82-920-1743    waterfol@ncc.re.kr   
Principal Investigator: Keun Won Ryu, PhD         
Sub-Investigator: You Jin Lee, PhD         
Sub-Investigator: Eun Kyung Lee         
Sub-Investigator: Mi Hyang Kwak, PhD         
Sub-Investigator: Hak Jin Kim, PhD         
Sub-Investigator: Sun Young Kong, PhD         
Sub-Investigator: Il Ju Choi, PhD         
Sub-Investigator: Chan Gyoo Kim, PhD         
Sub-Investigator: Jong Yeul Lee         
Sub-Investigator: Soo-Jeong Cho, PhD         
Sub-Investigator: Young-Woo Kim, PhD         
Sub-Investigator: Jun Ho Lee, PhD         
Sub-Investigator: Hong Man Yoon         
Sub-Investigator: Ji Yeon Park         
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Keun Won Ryu, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01643811     History of Changes
Other Study ID Numbers: 1210552-1
Study First Received: July 11, 2012
Last Updated: March 4, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
early gastric cancer, diabetes, hypertension

Additional relevant MeSH terms:
Hypertension
Stomach Neoplasms
Vascular Diseases
Cardiovascular Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 16, 2014