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• W1993348473 abstract "To the Editor:We read with interest the article by Andriulli et al.1.Andriulli A. Clemente R. Solmi L. Teruzzi V. Suriani R. Sigillito A. et al.Gabexate and somatostatin administration before ERCP in patients at high risk for ERCP pancreatitis: a multicentric, placebo-controlled, randomized clinical trial.Gastrointest Endosc. 2002; 56: 488-495Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar on the short-term prophylactic prevention of post-ERCP pancreatitis with gabexate and somatostatin. However, we cannot agree with the conclusions. The negative results of short-term treatment with gabexate in this trial may lead to a different interpretation.In an experimental model of pancreatic duct occlusion, a progressive rise in serum amylase activity over the 6 hours after ductal obstruction was associated with continued synthesis of digestive enzymes.2.Saluja A. Saluja M. Villa A. Leli U. Rutledge P. Meldolesi J. Steer M. Pancreatic duct obstruction in rabbits causes digestive zymogen and lysosomal enzyme colocalization.J Clin Invest. 1989; 84: 1260-1266Crossref PubMed Scopus (135) Google Scholar Therefore, the serum pancreatic enzyme peak detected within the first 4 hours after ERCP3.Gottlieb K. Sherman S. Pezzi J. Esher E. Lehman G.A. Early recognition of post-ERCP pancreatitis by clinical assessment and serum pancreatic enzymes.Am J Gastroenterol. 1996; 91: 1553-1557PubMed Google Scholar, 4.Messmann H. Vogt W. Holstege A. Lock G. Heinisch A. von Furstenberg A. et al.Post-ERCP pancreatitis as a model for cytokine-induced acute phase response in acute pancreatitis.Gut. 1997; 40: 80-85Crossref PubMed Scopus (89) Google Scholar might be the consequence of temporary obstruction of the main pancreatic duct. Pancreatic pain and pancreatitis start later4.Messmann H. Vogt W. Holstege A. Lock G. Heinisch A. von Furstenberg A. et al.Post-ERCP pancreatitis as a model for cytokine-induced acute phase response in acute pancreatitis.Gut. 1997; 40: 80-85Crossref PubMed Scopus (89) Google Scholar, 5.Cavallini G. Tittobello A. Frulloni L. Masci E. Mariana A. Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography.N Engl J Med. 1996; 335: 919-923Crossref PubMed Scopus (350) Google Scholar and may be the expression of acinar cell colocalization of lysosomal hydrolases and digestive zymogens induced by the occlusion of the pancreatic duct.2.Saluja A. Saluja M. Villa A. Leli U. Rutledge P. Meldolesi J. Steer M. Pancreatic duct obstruction in rabbits causes digestive zymogen and lysosomal enzyme colocalization.J Clin Invest. 1989; 84: 1260-1266Crossref PubMed Scopus (135) Google ScholarTherefore, it is possible that an infusion of gabexate starting 30 minutes before endoscopy and continuing for only 2 hours afterward is too short to interfere with the onset of post-procedural pancreatitis. In a study from our group,5.Cavallini G. Tittobello A. Frulloni L. Masci E. Mariana A. Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography.N Engl J Med. 1996; 335: 919-923Crossref PubMed Scopus (350) Google Scholar a longer infusion of gabexate (dose 1 g) from 30 to 90 minutes before ERCP and for 12 hours thereafter, significantly reduced the frequency of post-procedure pancreatitis compared with placebo.In an effort to reduce the cost of this lengthy schedule and to make such treatment practicable for outpatient ERCP, we conducted a randomized, controlled trial to assess whether a shorter gabexate infusion, starting 30 minutes before ERCP and continuing for 6 hours afterward, at a dose of 0.5 g, was as effective as the longer schedule.6.Masci E. Mariani A. Frulloni L. Curioni S. Generoso U. Costamagna G. Tittobello A. Cavallini G. the GRIGED II group, Milan, Italy Comparison of two dosing regimens of gabexate mesilate in the prevention of post-ERCP pancreatitis: results of a multicentre controlled trial.Am J Gastroenterol. 2003; (in press)PubMed Google Scholar We prospectively recruited 434 patients (201 men, 233 women; mean age 63.9 years, range 18-96 years) scheduled for ERCP in 25 Italian centers. The enrolled patients were randomized to two groups in double-blind fashion. All patients were first treated with a 0.5-g continuous intravenous infusion of gabexate starting 30 minutes before the endoscopy and continuing for 6 hours thereafter. The infusion of gabexate was continued over the next 6 hours and 30 minutes in 214 patients for a total of 1 g given over 13 hours (group I), while 220 patients (group II) were given placebo (saline solution). The overall frequency of acute pancreatitis was 1.8% (8 patients). In group I, the frequency was 1.4% (3 patients), and, in group II, it was 2.2% (5 patients). The shorter infusion (total 6.5 hours), at the same concentration, was as effective as the 13-hour infusion in reducing the frequency of post-ERCP pancreatitis. The peak serum levels of amylase and lipase, pancreatic pain, and need for analgesics were not significantly different between the two groups.The efficacy of the 6-hour infusion of gabexate after ERCP suggests that this interval is long enough for the drug to interfere with the pathophysiologic mechanisms of post-ERCP pancreatitis, whereas, this cannot happen with an infusion for only 2 hours after ERCP. The conclusions of Andriulli et al.1.Andriulli A. Clemente R. Solmi L. Teruzzi V. Suriani R. Sigillito A. et al.Gabexate and somatostatin administration before ERCP in patients at high risk for ERCP pancreatitis: a multicentric, placebo-controlled, randomized clinical trial.Gastrointest Endosc. 2002; 56: 488-495Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar concerning short-term prophylaxis with gabexate may be misleading, as the results were probably based on infusion of the drug for a period of time that is too short. To the Editor: We read with interest the article by Andriulli et al.1.Andriulli A. Clemente R. Solmi L. Teruzzi V. Suriani R. Sigillito A. et al.Gabexate and somatostatin administration before ERCP in patients at high risk for ERCP pancreatitis: a multicentric, placebo-controlled, randomized clinical trial.Gastrointest Endosc. 2002; 56: 488-495Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar on the short-term prophylactic prevention of post-ERCP pancreatitis with gabexate and somatostatin. However, we cannot agree with the conclusions. The negative results of short-term treatment with gabexate in this trial may lead to a different interpretation. In an experimental model of pancreatic duct occlusion, a progressive rise in serum amylase activity over the 6 hours after ductal obstruction was associated with continued synthesis of digestive enzymes.2.Saluja A. Saluja M. Villa A. Leli U. Rutledge P. Meldolesi J. Steer M. Pancreatic duct obstruction in rabbits causes digestive zymogen and lysosomal enzyme colocalization.J Clin Invest. 1989; 84: 1260-1266Crossref PubMed Scopus (135) Google Scholar Therefore, the serum pancreatic enzyme peak detected within the first 4 hours after ERCP3.Gottlieb K. Sherman S. Pezzi J. Esher E. Lehman G.A. Early recognition of post-ERCP pancreatitis by clinical assessment and serum pancreatic enzymes.Am J Gastroenterol. 1996; 91: 1553-1557PubMed Google Scholar, 4.Messmann H. Vogt W. Holstege A. Lock G. Heinisch A. von Furstenberg A. et al.Post-ERCP pancreatitis as a model for cytokine-induced acute phase response in acute pancreatitis.Gut. 1997; 40: 80-85Crossref PubMed Scopus (89) Google Scholar might be the consequence of temporary obstruction of the main pancreatic duct. Pancreatic pain and pancreatitis start later4.Messmann H. Vogt W. Holstege A. Lock G. Heinisch A. von Furstenberg A. et al.Post-ERCP pancreatitis as a model for cytokine-induced acute phase response in acute pancreatitis.Gut. 1997; 40: 80-85Crossref PubMed Scopus (89) Google Scholar, 5.Cavallini G. Tittobello A. Frulloni L. Masci E. Mariana A. Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography.N Engl J Med. 1996; 335: 919-923Crossref PubMed Scopus (350) Google Scholar and may be the expression of acinar cell colocalization of lysosomal hydrolases and digestive zymogens induced by the occlusion of the pancreatic duct.2.Saluja A. Saluja M. Villa A. Leli U. Rutledge P. Meldolesi J. Steer M. Pancreatic duct obstruction in rabbits causes digestive zymogen and lysosomal enzyme colocalization.J Clin Invest. 1989; 84: 1260-1266Crossref PubMed Scopus (135) Google Scholar Therefore, it is possible that an infusion of gabexate starting 30 minutes before endoscopy and continuing for only 2 hours afterward is too short to interfere with the onset of post-procedural pancreatitis. In a study from our group,5.Cavallini G. Tittobello A. Frulloni L. Masci E. Mariana A. Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography.N Engl J Med. 1996; 335: 919-923Crossref PubMed Scopus (350) Google Scholar a longer infusion of gabexate (dose 1 g) from 30 to 90 minutes before ERCP and for 12 hours thereafter, significantly reduced the frequency of post-procedure pancreatitis compared with placebo. In an effort to reduce the cost of this lengthy schedule and to make such treatment practicable for outpatient ERCP, we conducted a randomized, controlled trial to assess whether a shorter gabexate infusion, starting 30 minutes before ERCP and continuing for 6 hours afterward, at a dose of 0.5 g, was as effective as the longer schedule.6.Masci E. Mariani A. Frulloni L. Curioni S. Generoso U. Costamagna G. Tittobello A. Cavallini G. the GRIGED II group, Milan, Italy Comparison of two dosing regimens of gabexate mesilate in the prevention of post-ERCP pancreatitis: results of a multicentre controlled trial.Am J Gastroenterol. 2003; (in press)PubMed Google Scholar We prospectively recruited 434 patients (201 men, 233 women; mean age 63.9 years, range 18-96 years) scheduled for ERCP in 25 Italian centers. The enrolled patients were randomized to two groups in double-blind fashion. All patients were first treated with a 0.5-g continuous intravenous infusion of gabexate starting 30 minutes before the endoscopy and continuing for 6 hours thereafter. The infusion of gabexate was continued over the next 6 hours and 30 minutes in 214 patients for a total of 1 g given over 13 hours (group I), while 220 patients (group II) were given placebo (saline solution). The overall frequency of acute pancreatitis was 1.8% (8 patients). In group I, the frequency was 1.4% (3 patients), and, in group II, it was 2.2% (5 patients). The shorter infusion (total 6.5 hours), at the same concentration, was as effective as the 13-hour infusion in reducing the frequency of post-ERCP pancreatitis. The peak serum levels of amylase and lipase, pancreatic pain, and need for analgesics were not significantly different between the two groups. The efficacy of the 6-hour infusion of gabexate after ERCP suggests that this interval is long enough for the drug to interfere with the pathophysiologic mechanisms of post-ERCP pancreatitis, whereas, this cannot happen with an infusion for only 2 hours after ERCP. The conclusions of Andriulli et al.1.Andriulli A. Clemente R. Solmi L. Teruzzi V. Suriani R. Sigillito A. et al.Gabexate and somatostatin administration before ERCP in patients at high risk for ERCP pancreatitis: a multicentric, placebo-controlled, randomized clinical trial.Gastrointest Endosc. 2002; 56: 488-495Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar concerning short-term prophylaxis with gabexate may be misleading, as the results were probably based on infusion of the drug for a period of time that is too short." @default.
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