The "Prometeo" study: online collection of clinical data and outcome of Italian patients with acute nonvariceal upper gastrointestinal bleeding.
OBJECTIVE
To implement an online, prospective collection of clinical data and outcome of patients with acute nonvariceal upper gastrointestinal bleeding (UGIB) in Italy ("Prometeo" study).


BACKGROUND
Epidemiology, clinical features, and outcomes of nonvariceal UGIB are mainly known by retrospective studies and are probably changing.


METHODS
Data were collected by 13 Gastrointestinal Units in Italy from June 2006 to June 2007 (phase 1) and from December 2008 to December 2009 (phase 2): an interim analysis of data was performed between the 2 phases to optimize the online database. All the patients consecutively admitted for acute nonvariceal UGIB were enrolled. Demographic and clinical data were collected, a diagnostic endoscopy performed, with endoscopic hemostasis if indicated.


RESULTS
One thousand four hundred thirteen patients (M=932, mean age±SD=66.5±15.8; F=481, mean age±SD=74.2±14.6) were enrolled. Comorbidities were present in 83%. 52.4% were treated with acetyl salicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs): only 13.9% had an effective gastroprotection. Previous episodes of UGIB were present in 13.3%. Transfusion were needed in 43.9%. Shock was present in 9.3%. Endoscopic diagnosis was made in 93.2%: peptic lesions were the main cause of bleeding (duodenal ulcer 36.2%, gastric ulcer 29.6%, gastric/duodenal erosions 10.9%). At endoscopy, Helicobacter pylori was searched in 37.2%, and found positive in 51.3% of tested cases. Early rebleeding was observed in 5.4%: surgery was required in 14.3% of them. Bleeding-related death occurred in 4.0%: at multivariate analysis, the risk of death was correlated with female sex [odds ratio (OR=2.19, P=0.0089)], presence of neoplasia (OR=2.70, P=0.0057) or multiple comorbidities (OR=5.04, P=0.0280), shock at admission (OR=4.55, P=0.0001), and early rebleeding (OR=1.47, P=0.004).


CONCLUSIONS
Prometeo database has provided an up-to-date picture of acute nonvariceal UGIB in Italy: patients are elderly, predominantly males, and with important comorbidities. Gastroprotection is underutilized during NSAIDs treatment. With respect to previous studies, Prometeo shows a higher incidence of low-dose acetyl salicylic acid use and comorbidities, whereas no significant difference were found in other items (etiology of bleeding, NSAIDs use, need for endoscopic hemostasis, incidence of rebleeding, and overall mortality).
Gastroenterology, AOU Maggiore della Carità, Novara, Italy. mario.delpiano@alice.it
Mario
M
Del Piano
Maria Antonia
MA
Bianco
Livio
L
Cipolletta
Alessandro
A
Zambelli
Fausto
F
Chilovi
Giovanni
G
Di Matteo
Michela
M
Pagliarulo
Marco
M
Ballarè
Gianluca
G
Rotondano
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D001803:Blood Transfusion; D015897:Comorbidity; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis / Q000453:epidemiology* / Q000401:mortality / Q000628:therapy; D016481:Helicobacter Infections / Q000453:epidemiology; D016558:Hemostasis, Endoscopic; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000453:epidemiology; D016017:Odds Ratio; D010438:Peptic Ulcer Hemorrhage / Q000453:epidemiology; D011446:Prospective Studies; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D012769:Shock / Q000453:epidemiology; D013276:Stomach Ulcer / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal