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Trial registered on ANZCTR


Registration number
ACTRN12607000521426
Ethics application status
Approved
Date submitted
7/10/2007
Date registered
10/10/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The prevalence of Helicobacter pylori infection in patients with peptic ulcer disease complicated by haemorrhage after assumption of nonsteroidal anti-inflammatory drugs
Scientific title
The prevalence of Helicobacter pylori (Hp) infection in patients consecutively admitted during a 12-month period to the emergency unit of the A. Cardarelli Hospital of Naples for peptic ulcer disease complicated by haemorrhage after assumption of nonsteroidal anti-inflammatory drugs (NSAIDs): EMOFANS Study
Universal Trial Number (UTN)
Trial acronym
EMOFANS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Helicobacter pylori infection and NSAIDs use in patients with peptic ulcer disease complicated by haemorrhage 2431 0
Condition category
Condition code
Oral and Gastrointestinal 2533 2533 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study was planned to provide further information on the role of Hp in the pathogenesis of peptic ulcer disease complicated by haemorrhage in patients chronically or occasionally treated with NSAIDs. Data in literature are conflicting because studies were conducted by using different definitions of “NSAID user”, and with different methods for the detection of Hp infection. On the basis of the number of patients observed in our Unit during the previous 2 years, we plan to enrol 80 patients in 12 months.
Intervention code [1] 2153 0
Not applicable
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3434 0
Prevalence of Hp infection in patients with peptic ulcer disease complicated by haemorrhage after assumption of NSAIDs
Timepoint [1] 3434 0
During the in-hospital stay
Secondary outcome [1] 5709 0
Seroprevalence of anti-Cytotoxin-associated antigen A (CagA) antibodies
Timepoint [1] 5709 0
During the in-hospital stay
Secondary outcome [2] 5710 0
Identification of Hp stool antigen. For this purpose, a commercial kit (ImmunoCard STAT! HpSA; Meridian Bioscience Inc., Cincinnati, Ohio) will be used in this study.
Timepoint [2] 5710 0
During the in-hospital stay
Secondary outcome [3] 5711 0
The prevalence of NSAIDs users among all patients with peptic ulcer disease complicated by haemorrhage admitted to the emergency unit of the A. Cardarelli Hospital of Naples during a 12-month observation period
Timepoint [3] 5711 0
During the in-hospital stay
Secondary outcome [4] 5712 0
Incidence of peptic ulcer disease complicated by haemorrhage after assumption of NSAIDs in our cohort of patients compared to that observed in Italy and reported in the "Rete Nazionale di Farmacovigilanza (http://www.aifa.gov.it)" database of the same time period
Timepoint [4] 5712 0
During the in-hospital stay

Eligibility
Key inclusion criteria
Patients with peptic ulcer disease complicated by haemorrhage (Hematemesis, melena, ematochezia, or with other clinical signs of blood loss - i.e., hemodynamic instability with hypotension and tachycardia) within 72 hours before admission;
Continuative or occasional use of nonsteroidal anti-inflammatory drugs within 30 days before admission;
Ulcer with a diameter of at least 5 mm;
Ability to understand and follow the protocol requirements;
Having given written informed consent form for study participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients in treatment with antibiotics and proton-pump inhibitors within 4 weeks before the enrolment;
Patients with upper gastrointestinal neoplastic ulcer

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 617 0
Italy
State/province [1] 617 0

Funding & Sponsors
Funding source category [1] 2682 0
Hospital
Name [1] 2682 0
AORN A. Cardarelli
Country [1] 2682 0
Italy
Primary sponsor type
Individual
Name
Dr. Antonio Balzano
Address
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country
Italy
Secondary sponsor category [1] 2426 0
Individual
Name [1] 2426 0
Dr. Annamaria Nicchia
Address [1] 2426 0
AORN A. Cardarelli
UOC di Farmacia
Via A. Cardarelli 9
80131 Napoli
Country [1] 2426 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4610 0
Comitato Etico AORN "A.Cardarelli"
Ethics committee address [1] 4610 0
Via A. Cardarelli 9
80131 Napoli
e-mail: [email protected]
Ethics committee country [1] 4610 0
Italy
Date submitted for ethics approval [1] 4610 0
Approval date [1] 4610 0
03/10/2007
Ethics approval number [1] 4610 0

Summary
Brief summary
This single-centre, observational, prospective study, involving the A. Cardarelli Hospital, a high volume hospital dedicated to the emergency, located centrally in Naples with a catchment area of over 1.4 million inhabitants, was planned because of two favorable conditions. The first was the high number of patients referred to the hospital for upper gastrointestinal bleeding that allowed a single-centre prospective study, and the second was the presence of a rota of gastroenterologists skilled in diagnostic and therapeutic measures available 24 hours a day, seven days a week, not as 24-hour on phone call service, able to enrol all consecutive patients. This study was planned to obtain information about the role of Helicobacter pylori (Hp) infection in patients assuming continuative or occasional nonsteroidal anti-inflammatory drugs (NSAIDs) and admitted to the emergency unit of A. Cardarelli Hospital for peptic ulcer disease complicated by haemorrhage. There is one primary objective in this study: the prevalence of Hp infection in patients with peptic ulcer disease complicated by haemorrhage after assumption of NSAIDs, and four secondary objectives: 1) identification of Hp stool antigen; 2) seroprevalence of Hp CagA; 3) prevalence of NSAIDs users among all patients with peptic ulcer disease complicated by haemorrhage admitted to the emergency unit of A. Cardarelli Hospital; and 4) incidence of peptic ulcer disease complicated by haemorrhage after assumption of NSAIDs in our cohort of patients compared to that observed in Italy and reported in the "Rete Nazionale di Farmacovigilanza (http://www.aifa.gov.it)" database regarding the same time period. For this purpose we will recruit all consecutive patients with upper gastrointestinal bleeding from complicated peptic ulcer and in treatment with NSAIDs, admitted to the emergency unit of the A. Cardarelli Hospital of Naples during a 12-month observation period. Patients will have to present the following criteria: male or female patients, of any ethnic origin, 18 years or more of age, who provide written informed consent prior to any study-related procedures and who are, in the opinion of the Investigator, able to understand and to follow the protocol and likely to comply with all the requirements of the study. A total of 80 patients are required to complete the study. The inclusion criteria are: 1) patients with peptic ulcer disease complicated by haemorrhage (hematemesis, melena, ematochezia, or with other clinical signs of blood loss - i.e., hemodynamic instability with hypotension and tachycardia) within 72 hours before admission; 2) continuative or occasional use of nonsteroidal anti-inflammatory drugs within 30 days before admission; 3) ulcer with a diameter of at least 5 mm; 4) ability to understand and follow the protocol requirements; 5) having given written informed consent form for study participation. The exclusion criteria are: 1) patients in treatment with antibiotics and proton-pump inhibitors within 4 weeks before the enrolment to avoid false negative Hp results; 2) patients with upper gastrointestinal neoplastic ulcer. The study plan includes upper endoscopy (EGD) in each patient to evaluate the source of upper gastrointestinal bleeding and to perform biopsy in eligible subjects (3 from antrum and 3 from gastric body greater curve for the Hp research, and from all suspected lesions). The 3 specimens from antrum and gastric body will be used for: a) rapid urease (CLO) test for Hp; b) the presence of Hp on tissue sections; c) culture of biopsy specimens for Hp. Hp infection will be researched in all these different ways at the same time: 1) culture of biopsy specimens; 2) CLO test; 3) the presence of Hp on tissue sections; 4) serum CagA antibodies; and 5) identification of Hp stool antigen. The gold standard to identify patient Hp infected will be the positive culture of biopsy specimens or the contemporary positivity of CLO test and the presence of Hp on tissue sections according to the current guidelines. Patients’ information will be collected in a database: 1) demographic; 2) comorbidities according to the Charlson Comorbidity Index; 3) clinical and biochemical parameters; 4) continuative or occasional use of NSAIDs and antithombotics; 5) treatments administered during the in-hospital stay; 6) endoscopy findings; 7) histology findings; 8) microbiology results. This study will be conducted in compliance with the Declaration of Helsinki (1964 and successive amendments), current Good Clinical Practices and the applicable European and local regulatory requirements. SPSS software package for Windows (release 15.0.0 or higher; SPSS Inc., Chicago, IL, USA) will be used for statistical analysis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28094 0
Address 28094 0
Country 28094 0
Phone 28094 0
Fax 28094 0
Email 28094 0
Contact person for public queries
Name 11251 0
Dott. Francesco Manguso
Address 11251 0
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country 11251 0
Italy
Phone 11251 0
+39-081-7474034
Fax 11251 0
+39-081-7474034
Email 11251 0
[email protected]
Contact person for scientific queries
Name 2179 0
Dott. Francesco Manguso
Address 2179 0
AORN A. Cardarelli
UOC di Gastroenterologia
Via A. Cardarelli 9
80131 Napoli
Country 2179 0
Italy
Phone 2179 0
+39-081-7474034
Fax 2179 0
+39-081-7474034
Email 2179 0
[email protected]

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