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

NCT ID: NCT01643811

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Early Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastrectomy

Patients who underwent gastrectomy for early gastric cancer

gastrectomy

Intervention Type PROCEDURE

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

Endoscopic submucosal dissection

Intervention Type PROCEDURE

endoscopic submucosal dissection

Interventions

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gastrectomy

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

Intervention Type PROCEDURE

Endoscopic submucosal dissection

endoscopic submucosal dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Keun Won Ryu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center

Goyang, Kyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1210552-1

Identifier Type: -

Identifier Source: org_study_id

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