The prevalence of Helicobacter pylori infection in patients with peptic ulcer disease complicated by haemorrhage after assumption of nonsteroidal anti-inflammatory drugs

None listed

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

No related papers found yet.