Distribution of Helicobacter Pylori After Gastrectomy

Helicobacter Pylori Infections Clinical Trial

Official title:

Distribution of Helicobacter Pylori in Remnant Stomach After Subtotal Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03419936
• Other study ID #: 2015-0823
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2018
• Last updated: January 27, 2018
• Start date: March 21, 2016
• Est. completion date: March 21, 2020

Study information

• Verified date: January 2018
• Source: Asan Medical Center
• Contact: myungeun Lee, BA
• Phone: +82-2-3010-7190
• Email: lme23[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to know the distribution of Helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

Description:

Endoscopy and biopsy will be performed to investigate the distribution of Helicobacter pylori before and after subtotal gastrectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 21, 2020
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients who are indicated to subtotal gastrectomy due to gastric neoplasm

2. Aged between 19 to 75 years

3. Informed consent

Exclusion Criteria:

1. Previous history of Helicobacter pylori eradication

2. Previous history of proton pump inhibitor use within 6 months

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infections

Intervention

Diagnostic Test:
• Endoscopic biopsy
Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy. Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy. Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of Helicobacter Pylori After Gastrectomy	Analysis the change of Helicobacter pylori according to the subtotal gastrectomy	Change in the distribution of Helicobacter Pylori at 2 years
Secondary	Change of atrophy after gastrectomy	Analysis the change of atrophic status according to the subtotal gastrectomy	Change in the atrophic status at 2 years