Natural History of Non-steroidal Anti-inflammatory Drug and Non-Helicobacter Pylori in Bleeding Peptic Ulcers

Completed

• Conditions: Peptic Ulcer

• Registration Number: NCT00153712
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The aim of this study is to study the natural history of the ulcer healing while on proton pump inhibitors (PPI) and the ulcer recurrence without acid suppression therapy of Non-steroidal Anti-inflammatory Drugs (NSAID), non-Helicobacter pylori (HP) bleeding ulcer patients.

Detailed Description

Non-steroidal Anti-inflammatory Drugs (NSAID), Non-Helicobacter pylori (HP) bleeding peptic ulcers are relatively common in the West (11%-44%). It is uncommon in Hong Kong (4%). Significant number of these patients with non-NSAID, non-Hp bleeding ulcers had co-morbid illness and many had life-threatening conditions. Our recent study showed that there is an increasing incidence of non-steroidal anti-inflammatory drugs (NSAID), non-Helicobacter pylori (Hp) bleeding peptic ulcers. There is no datum on the natural course of these patients and this is our aim to have this observational study.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

• Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer
• Age > 18 years old
• Informed consent

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Exclusion Criteria

• Concommitant use of high dose steroid or warfarin
• New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors
• Renal failure (serum creatinine > 200umol/l)
• Previous gastric surgery
• Oesophagitis, esophageal varices
• Terminal illness or malignancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrent ulcer bleeding	During the observation period	Hematemesis or melena documented by the admitting physician, or a decrease in the hemoglobin level of at least 2 g/dL, with ulcers or bleeding erosions confirmed on endoscopy.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	During the observation period	The secondary endpoint is recurrent lower gastrointestinal (GI) bleeding, which was defined as recurrent overt bleeding (melena or hematochezia without an upper GI source) or a drop in hemoglobin \>2 g/dL, without an upper GI source or other non-GI causes of anemia. We excluded hemorrhoidal bleeding and colorectal cancer as lower GI outcomes.

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Shatin, Hong Kong, China