The "Prometeo" study: Online collection of clinical data and outcome of italian patients with acute nonvariceal upper gastrointestinal bleeding

Mario Del Piano, Maria Antonia Bianco, Livio Cipolletta, Alessandro Zambelli, Fausto Chilovi, Giovanni Di Matteo, Michela Pagliarulo, Marco Ballarè, Gianluca Rotondano, Franco Montino, Anderloni Andrea, Balzarini Marco, Maria Antonia Bianco, Gianfranco Brambilla, Margit Battisti Matscher, Emilio Di Giulio, Attilia Fabio, Enrico Ricci, Claudio Cortini, Giorgio FrosiniMario Marini, Pietro Leo, Giusy Franco, Renato Cuppone, Leonardo Ficano, Pietro Loriga, Antonella Atzei, Alberto Prada, Ilaria Arena, Luigi Buri, Catrin Simeth

Research output: Contribution to journalArticle

Abstract

GOALS: 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. STUDY: 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).

Original languageEnglish
JournalJournal of Clinical Gastroenterology
Volume47
Issue number4
DOIs
Publication statusPublished - Apr 2013

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Hemorrhage
Comorbidity
Endoscopic Hemostasis
Italy
Anti-Inflammatory Agents
Salicylic Acid
Endoscopy
Shock
Pharmaceutical Preparations
Databases
Incidence
Sex Ratio
Stomach Ulcer
Duodenal Ulcer
Helicobacter pylori
Digestion
Stomach
Epidemiology
Multivariate Analysis
Retrospective Studies

Keywords

  • Endoscopic hemostasis
  • Nonvariceal upper gastrointestinal bleeding
  • Peptic ulcer
  • Proton pump inhibitors
  • Upper gastrointestinal endoscopy

ASJC Scopus subject areas

  • Gastroenterology

Cite this

The "Prometeo" study : Online collection of clinical data and outcome of italian patients with acute nonvariceal upper gastrointestinal bleeding. / Del Piano, Mario; Antonia Bianco, Maria; Cipolletta, Livio; Zambelli, Alessandro; Chilovi, Fausto; Di Matteo, Giovanni; Pagliarulo, Michela; Ballarè, Marco; Rotondano, Gianluca; Montino, Franco; Andrea, Anderloni; Marco, Balzarini; Bianco, Maria Antonia; Brambilla, Gianfranco; Matscher, Margit Battisti; Di Giulio, Emilio; Fabio, Attilia; Ricci, Enrico; Cortini, Claudio; Frosini, Giorgio; Marini, Mario; Leo, Pietro; Franco, Giusy; Cuppone, Renato; Ficano, Leonardo; Loriga, Pietro; Atzei, Antonella; Prada, Alberto; Arena, Ilaria; Buri, Luigi; Simeth, Catrin.

In: Journal of Clinical Gastroenterology, Vol. 47, No. 4, 04.2013.

Research output: Contribution to journalArticle

Del Piano, M, Antonia Bianco, M, Cipolletta, L, Zambelli, A, Chilovi, F, Di Matteo, G, Pagliarulo, M, Ballarè, M, Rotondano, G, Montino, F, Andrea, A, Marco, B, Bianco, MA, Brambilla, G, Matscher, MB, Di Giulio, E, Fabio, A, Ricci, E, Cortini, C, Frosini, G, Marini, M, Leo, P, Franco, G, Cuppone, R, Ficano, L, Loriga, P, Atzei, A, Prada, A, Arena, I, Buri, L & Simeth, C 2013, 'The "Prometeo" study: Online collection of clinical data and outcome of italian patients with acute nonvariceal upper gastrointestinal bleeding', Journal of Clinical Gastroenterology, vol. 47, no. 4. https://doi.org/10.1097/MCG.0b013e3182617dcc
Del Piano, Mario ; Antonia Bianco, Maria ; Cipolletta, Livio ; Zambelli, Alessandro ; Chilovi, Fausto ; Di Matteo, Giovanni ; Pagliarulo, Michela ; Ballarè, Marco ; Rotondano, Gianluca ; Montino, Franco ; Andrea, Anderloni ; Marco, Balzarini ; Bianco, Maria Antonia ; Brambilla, Gianfranco ; Matscher, Margit Battisti ; Di Giulio, Emilio ; Fabio, Attilia ; Ricci, Enrico ; Cortini, Claudio ; Frosini, Giorgio ; Marini, Mario ; Leo, Pietro ; Franco, Giusy ; Cuppone, Renato ; Ficano, Leonardo ; Loriga, Pietro ; Atzei, Antonella ; Prada, Alberto ; Arena, Ilaria ; Buri, Luigi ; Simeth, Catrin. / The "Prometeo" study : Online collection of clinical data and outcome of italian patients with acute nonvariceal upper gastrointestinal bleeding. In: Journal of Clinical Gastroenterology. 2013 ; Vol. 47, No. 4.
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abstract = "GOALS: 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. STUDY: 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).",
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TY - JOUR

T1 - The "Prometeo" study

T2 - Online collection of clinical data and outcome of italian patients with acute nonvariceal upper gastrointestinal bleeding

AU - Del Piano, Mario

AU - Antonia Bianco, Maria

AU - Cipolletta, Livio

AU - Zambelli, Alessandro

AU - Chilovi, Fausto

AU - Di Matteo, Giovanni

AU - Pagliarulo, Michela

AU - Ballarè, Marco

AU - Rotondano, Gianluca

AU - Montino, Franco

AU - Andrea, Anderloni

AU - Marco, Balzarini

AU - Bianco, Maria Antonia

AU - Brambilla, Gianfranco

AU - Matscher, Margit Battisti

AU - Di Giulio, Emilio

AU - Fabio, Attilia

AU - Ricci, Enrico

AU - Cortini, Claudio

AU - Frosini, Giorgio

AU - Marini, Mario

AU - Leo, Pietro

AU - Franco, Giusy

AU - Cuppone, Renato

AU - Ficano, Leonardo

AU - Loriga, Pietro

AU - Atzei, Antonella

AU - Prada, Alberto

AU - Arena, Ilaria

AU - Buri, Luigi

AU - Simeth, Catrin

PY - 2013/4

Y1 - 2013/4

N2 - GOALS: 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. STUDY: 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).

AB - GOALS: 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. STUDY: 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).

KW - Endoscopic hemostasis

KW - Nonvariceal upper gastrointestinal bleeding

KW - Peptic ulcer

KW - Proton pump inhibitors

KW - Upper gastrointestinal endoscopy

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