Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients - Full Text View

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:

MedlinePlus related topics: Cancer Diabetes Endoscopy High Blood Pressure Metabolic Disorders Stomach Cancer

U.S. FDA Resources

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 May 23, 2013