NCT00441831

Brief Summary

Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged supporting the link between the chronic gastritis of HP infection and malignancy in adults, specifically gastric lymphoma and adenocarcinoma. The potential of HP eradication for the prevention of gastric cancer was underlined. At the national consensus meeting held in Brussels in 1998, HP eradication was strongly recommended in past or current peptic ulcer diseases, regardless of activity, complication and post endoscopic resection of early cancer. Some patients received gastric surgery due to the complications of peptic ulcer such as bleeding or perforation in the pre-HP eradication era. Their HP infection status was not surveyed and unknown at the time. Afterward, some of them were not suggested to receive an eradication therapy and recovered from the operative procedure. According to the consensus to treat HP for a purpose to reduce the risk of gastric cancer, these patients were still under risk. There have been only a few surveys on the prevalence of persistent HP infection in patients who have undergone surgery. The aim of the study was to evaluate the prevalence and histological features of HP infection after a time course of partial distal gastric surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

First QC Date

February 27, 2007

Last Update Submit

February 4, 2009

Conditions

Keywords

Helicobacter pylori infectionpeptic ulcer diseasedistal partial gastrectomybile refluxgastritisgastrectomy

Eligibility Criteria

Age15 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with previous distal gastrectomy

You may qualify if:

  • Previous distal gastrectomy

You may not qualify if:

  • Post HP eradication therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (4)

  • Fukuhara K, Osugi H, Takada N, Takemura M, Lee S, Taguchi S, Kaneko M, Tanaka Y, Fujiwara Y, Nishizawa S, Kinoshita H. Duodenogastric reflux eradicates Helicobacter pylori after distal gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1548-50.

    PMID: 15362798BACKGROUND
  • Huang WH, Wang HH, Wu WW, Lai HC, Hsu CH, Cheng KS. Helicobacter pylori infection in patients with ulcer recurrence after partial gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1551-3.

    PMID: 15362799BACKGROUND
  • Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.

    PMID: 17170018BACKGROUND
  • Johannesson KA, Hammar E, Stael von Holstein C. Mucosal changes in the gastric remnant: long-term effects of bile reflux diversion and Helicobacter pylori infection. Eur J Gastroenterol Hepatol. 2003 Jan;15(1):35-40. doi: 10.1097/00042737-200301000-00007.

    PMID: 12544692BACKGROUND

MeSH Terms

Conditions

Peptic UlcerBile RefluxGastritis

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesBiliary Tract DiseasesDuodenogastric RefluxGastroenteritis

Study Officials

  • Ming-Jen Chen, M.D.,M.S.

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2007

First Posted

March 1, 2007

Study Start

February 1, 2007

Study Completion

February 1, 2008

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations