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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT00153712

Collaborator

(none)

391

Enrollment

Location

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer

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 Design

Study Type:

Observational

Actual Enrollment :

391 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Cohort Study to Study the Natural History and Ulcer Recurrence Without Acid Suppression of Non-NSAID, Non-HP Bleeding Peptic Ulcer Patients

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Non NSAID non-Hp Patient of history of peptic ulcer bleeding with Hp-ve and without prior history of taking NSAID or Aspirin within 30 days
Helicobacter pylori +ve Patient with Hp+ve at peptic ulcer bleeding

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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