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NCT Number: NCT01643811

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

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.

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Key information

Conditions

Early Gastric Cancer Cardiovascular Diseases Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Glucose Metabolism Disorders Hypertension Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Stomach Diseases Stomach Neoplasms Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center

Goyang, Kyeonggi-do, 410-769, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gastrectomy

Procedure

subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy

Endoscopic submucosal dissection

Procedure

endoscopic submucosal dissection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2012
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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