Distribution of Helicobacter Pylori After Gastrectomy

NCT03419936 | Unknown

• 1 other identifier: 2015-0823
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Infections

Keywords

Stomach Neoplasms; Helicobacter pylori; Subtotal gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of atrophy after gastrectomy

  Change in the atrophic status at 2 years

Study Arms (1)

Helicobacter pylori(HP) positive

Participants who are diagnosed with gastric cancer and Helicobacter Pylori infection will be treated with subtotal gastrectomy.

Diagnostic Test: Endoscopic biopsy

Interventions

Endoscopic biopsy DIAGNOSTIC_TEST

1. Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori 2. Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy. 3. Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy. 4. Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.

Helicobacter pylori(HP) positive

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample size will be determined based on the analysis the distribution rate of Helicobacter pylori at first 60 patients.

You may qualify if:

• Patients who are indicated to subtotal gastrectomy due to gastric neoplasm
• Aged between 19 to 75 years
• Informed consent

You may not qualify if:

• Previous history of Helicobacter pylori eradication
• Previous history of proton pump inhibitor use within 6 months

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endoscopic biopsy

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Ji Yong Ahn, Professor

  Study Principal Investigator Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

myungeun Lee, BA

CONTACT

+82-2-3010-7190; lme23@amc.seoul.kr

Sojung Park, BA

CONTACT

+82-2-3010-7190; sojung@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 5, 2018
• Study Start: March 21, 2016
• Primary Completion: March 21, 2020
• Study Completion: March 21, 2020
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)