Helicobacter Pylori and the Long-term Risk of Peptic Ulcer Bleeding

NCT01591486 | Completed

• 1 other identifier: 2NA3NANC
• Study Type: observational
• Target: 904
• Locations: 1 country
• Sites: 1

Brief Summary

Low-dose aspirin (ASA) has emerged as the most important cause of peptic ulcer bleeding worldwide. In western countries, ASA has overtaken non steroidal antiinflammatory drugs (NSAIDs) as a major cause of peptic ulcer bleeding in the elderly population \[1,2\]. Management of peptic ulcer bleeding in patients receiving ASA for cardiothrombotic diseases is a clinical dilemma. In a randomized trial of continuous versus interrupted ASA therapy after endoscopic treatment of peptic ulcer bleeding, patients who discontinued ASA had a 10-fold increased incidence of all-cause mortality compared to those who received continuous ASA therapy. On the other hand, patients receiving continuous ASA therapy had a two-fold increased risk of early rebleeding \[3\]. Thus, preventing the occurrence of peptic ulcer bleeding in ASA users is important in reducing morbidity and mortality. Given the uncertain clinical utility of Helicobacter Pylori (Hp) testing in ASA users, this prospective cohort study aims to determine whether testing for Hp will have any impact on the long-term incidence of ulcer bleeding in ASA users with high ulcer risk. The investigators hypothesize that among ASA users with Hp infection and ulcer bleeding, the long-term incidence of recurrent ulcer bleeding with ASA use will be low after eradication of Hp alone.

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori); Peptic Ulcer Bleeding

Keywords

Helicobacter pylori (Hp); ASA users; peptic ulcer bleeding; cohorts

Outcome Measures

Primary Outcomes (1)

• The cumulative incidence of gastroduodenal ulcer bleeding

  The cumulative incidence of gastroduodenal ulcer bleeding with ASA use in 10 years. Gastroduodenal ulcer bleeding is defined as haematemesis and/or melaena with gastroduodenal ulcers, or erosions with blood in the stomach confirmed by endoscopy, or a decrease in the haemoglobin level \>2 g/dL in the presence of endoscopically proven ulcers.

  10 years

Study Arms (3)

Hp-negative cohort

Hp-negative cohort The second cohort consists of ASA users with ulcer bleeding but no current or past Hp infection, as evidenced by: 1. negative rapid urease test 2. negative histology for Hp infection on both initial and follow-up endoscopy 3. negative serology test 4. absence of intestinal metaplasia and atrophy on 4 random biopsies of the antrum and corpus After ulcer healing, the Hp-negative cohort will receive enteric-coated ASA (\<160 mg daily) without regular co-prescription of anti-ulcer drugs.

Hp-eradicated cohort

Hp-eradicated cohort This cohort consists of ASA users with ulcer bleeding and Hp infection who have healed ulcers and successful eradication of Hp on follow-up endoscopy. They will receive plain ASA (\<160 mg daily) without co-prescription of anti-ulcer drugs.

Average-risk cohort

Average-risk cohort The third cohort consists of ASA-naive patients without a history of ulcer who attend the general outpatient clinic. They require long-term ASA for established cardiothrombotic diseases. They receive plain ASA (\<160 mg daily) without co-prescription of anti-ulcer drugs. Hp status will not be determined in this cohort because Hp testing is not justified in average-risk asymptomatic patients.

Eligibility Criteria

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

Study Population

Consecutive users of ASA presented with upper gastrointestinal bleeding to the Endoscopy Centre of the Prince of Wales Hospital will be screened for eligibility. The Prince of Wales Hospital serves a local population of 1.5 million people in Hong Kong. All patients undergo endoscopy within 24 hours of hospitalisation to identify the source of bleeding, to secure haemostasis, and to determine their Hp status.

You may qualify if:

• Gastroduodenal ulcer bleeding confirmed by endoscopy
• Anticipated regular use of ASA for cardiothrombotic diseases

You may not qualify if:

• Uncontrolled bleeding requiring surgical intervention
• Previous gastric surgery except for a patch repair
• Gastroesophageal varices
• Gastric-outlet obstruction
• Gastroesophageal reflux disease requiring regular acid suppressive therapy
• Renal failure (defined by a serum creatinine level of more than 200 μmol per liter)
• Moribund conditions
• Active malignancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong (sar), 852, China

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis KL CHAN, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 4, 2012
• Study Start: January 1, 1995
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 13, 2015

Record last verified: 2014-11

Locations

CN (1)