Prophylaxis of Post–Endoscopic Retrograde Cholangiopancreatography Pancreatitis by an Endoscopic Pancreatic Spontaneous Dislodgement Stent
2007; Elsevier BV; Volume: 5; Issue: 11 Linguagem: Inglês
10.1016/j.cgh.2007.07.008
ISSN1542-7714
AutoresAtsushi Sofuni, Hiroyuki Maguchi, Takao Itoi, Akio Katanuma, Hiroyuki Hisai, Teitetsu Niido, Masayuki Toyota, Tsuneshi Fujii, Youji Harada, Tadanori Takada,
Tópico(s)Pancreatic and Hepatic Oncology Research
ResumoBackground & Aims: Pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) is the most common and potentially serious complication of ERCP. The frequency of post-ERCP pancreatitis generally is reported to be between 1% and 9%. One cause of pancreatitis is retention of pancreatic juice resulting from papilledema after the procedure. We conducted a randomized controlled multicenter study to evaluate whether placement of a temporary pancreatic stent designed for spontaneous dislodgement prevents post-ERCP pancreatitis. Methods: The subjects were 201 consecutive patients who underwent ERCP. The patients were randomized into the stent placement group (S group = 98) or the nonstent placement group (nS group = 103). The stent used was 5F in diameter, 3 cm in length, straight, and unflanged inside. Results: Stents were placed successfully in 96% of the S group, and spontaneous stent dislodgment was recognized in 95.7% of those. The mean duration to dislodgment was 2 days, and there were no severe complications. The overall frequency of post-ERCP pancreatitis was 8.5%. The frequency of post-ERCP pancreatitis in the S and nS groups was 3.2% and 13.6%, respectively, showing a significantly lower frequency in the S group (P = .019). The mean increase in amylase level in the pancreatitis patients was significantly higher in the nS group (P = .014). Conclusions: The randomized controlled multicenter trial showed that placement of a pancreatic spontaneous dislodgment stent significantly reduces post-ERCP pancreatitis. Background & Aims: Pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) is the most common and potentially serious complication of ERCP. The frequency of post-ERCP pancreatitis generally is reported to be between 1% and 9%. One cause of pancreatitis is retention of pancreatic juice resulting from papilledema after the procedure. We conducted a randomized controlled multicenter study to evaluate whether placement of a temporary pancreatic stent designed for spontaneous dislodgement prevents post-ERCP pancreatitis. Methods: The subjects were 201 consecutive patients who underwent ERCP. The patients were randomized into the stent placement group (S group = 98) or the nonstent placement group (nS group = 103). The stent used was 5F in diameter, 3 cm in length, straight, and unflanged inside. Results: Stents were placed successfully in 96% of the S group, and spontaneous stent dislodgment was recognized in 95.7% of those. The mean duration to dislodgment was 2 days, and there were no severe complications. The overall frequency of post-ERCP pancreatitis was 8.5%. The frequency of post-ERCP pancreatitis in the S and nS groups was 3.2% and 13.6%, respectively, showing a significantly lower frequency in the S group (P = .019). The mean increase in amylase level in the pancreatitis patients was significantly higher in the nS group (P = .014). Conclusions: The randomized controlled multicenter trial showed that placement of a pancreatic spontaneous dislodgment stent significantly reduces post-ERCP pancreatitis. Postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, the most common and potentially serious complication of ERCP, is reported to occur in 1%–40% of cases in recent large prospective studies.1Freeman M.L. Nalini M. Guda M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar, 2Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1011) Google Scholar, 3Cheng C.L. Sherman S. Watkins J.L. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 2006; 101: 139-147Crossref PubMed Scopus (495) Google Scholar, 4Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2210) Google Scholar, 5Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 6Mehta S.N. Pavone E. Barkun J.S. et al.Predictors of post-ERCP complications in patients with suspected choledocholithiasis.Endoscopy. 1998; 30: 457-463Crossref PubMed Scopus (114) Google Scholar, 7Sherman S. Ruffolo T.A. Hawes R.H. et al.A prospective series with emphasis on the increased risk associates with sphincter of Oddi dysfunction and nondilated bile ducts.Gastroenterology. 1991; 101: 778-782Google Scholar, 8Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (487) Google Scholar, 9Elton E. Howell D.A. Parsons W.G. et al.Endoscopic pancreatic sphincterotomy: indications, outcome, and a safe stentless technique.Gastrointest Endosc. 1998; 47: 240-249Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar, 10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar, 11Tarnasky P.R. Palesch Y.Y. Cunningham J.T. et al.Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.Gastroenterology. 1998; 115: 1518-1524Abstract Full Text Full Text PDF PubMed Scopus (374) Google Scholar, 12Smithline A. Silverman W. Rogers D. et al.Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.Gastrointest Endosc. 1993; 39: 652-657Abstract Full Text PDF PubMed Scopus (191) Google Scholar, 13Singh P. Das A. Isenberg G. et al.Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.Gastrointest Endosc. 2004; 60: 544-550Abstract Full Text Full Text PDF PubMed Scopus (315) Google Scholar, 14Catalano M.F. Linder J.D. Chak A. et al.Endoscopic management of adenoma of the major duodenal papilla.Gastrointest Endosc. 2004; 59: 225-232Abstract Full Text Full Text PDF PubMed Scopus (293) Google Scholar, 15Tsuchiya T. Itoi T. Sofuni A. et al.A temporary inner unflanged 5Fr pancreatic duct stent to prevent post-ERCP pancreatitis A preliminary and single center randomized controlled trial study.Hep Bil Pancreatsurg. 2006; (in press)Google Scholar, 16Sherman S. Lehman G. Freeman M. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 1997; 92: 1639Google Scholar Some investigators have reported several factors that increase the risk of post-ERCP pancreatitis.1Freeman M.L. Nalini M. Guda M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar, 2Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1011) Google Scholar, 3Cheng C.L. Sherman S. Watkins J.L. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 2006; 101: 139-147Crossref PubMed Scopus (495) Google Scholar, 4Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2210) Google Scholar, 5Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 6Mehta S.N. Pavone E. Barkun J.S. et al.Predictors of post-ERCP complications in patients with suspected choledocholithiasis.Endoscopy. 1998; 30: 457-463Crossref PubMed Scopus (114) Google Scholar, 7Sherman S. Ruffolo T.A. Hawes R.H. et al.A prospective series with emphasis on the increased risk associates with sphincter of Oddi dysfunction and nondilated bile ducts.Gastroenterology. 1991; 101: 778-782Google Scholar, 8Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (487) Google Scholar, 9Elton E. Howell D.A. Parsons W.G. et al.Endoscopic pancreatic sphincterotomy: indications, outcome, and a safe stentless technique.Gastrointest Endosc. 1998; 47: 240-249Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar, 10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar, 11Tarnasky P.R. Palesch Y.Y. Cunningham J.T. et al.Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.Gastroenterology. 1998; 115: 1518-1524Abstract Full Text Full Text PDF PubMed Scopus (374) Google Scholar, 12Smithline A. Silverman W. Rogers D. et al.Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.Gastrointest Endosc. 1993; 39: 652-657Abstract Full Text PDF PubMed Scopus (191) Google Scholar, 13Singh P. Das A. Isenberg G. et al.Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.Gastrointest Endosc. 2004; 60: 544-550Abstract Full Text Full Text PDF PubMed Scopus (315) Google Scholar, 14Catalano M.F. Linder J.D. Chak A. et al.Endoscopic management of adenoma of the major duodenal papilla.Gastrointest Endosc. 2004; 59: 225-232Abstract Full Text Full Text PDF PubMed Scopus (293) Google Scholar, 15Tsuchiya T. Itoi T. Sofuni A. et al.A temporary inner unflanged 5Fr pancreatic duct stent to prevent post-ERCP pancreatitis A preliminary and single center randomized controlled trial study.Hep Bil Pancreatsurg. 2006; (in press)Google Scholar, 16Sherman S. Lehman G. Freeman M. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 1997; 92: 1639Google Scholar, 17Freeman M.L. Role of pancreatic stents in prevention of post-ERCP pancreatitis.J Pancreas. 2004; 5: 322-327PubMed Google Scholar, 18Fogel E.L. Eversman D. Jamidar P. et al.Sphincter of Oddi dysfunction: pancreaticobiliary sphincterotomy with pancreatic stent placement has a lower rate of pancreatitis than biliary sphincterotomy alone.Endoscopy. 2002; 34: 280-285Crossref PubMed Scopus (181) Google Scholar, 19Aizawa T. Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.Gastrointest Endosc. 2001; 54: 209123Abstract Full Text Full Text PDF Scopus (132) Google Scholar, 20Freeman M.L. Overby C. Qi D. Pancreatic stent insertion: consequence of failure and results of a modified technique to maximize success.Gastrointest Endosc. 2004; 59: 8-14Abstract Full Text Full Text PDF PubMed Scopus (177) Google Scholar, 21Vandervoort J. Soetikno R.M. Montes H. et al.Accuracy and complication rate of brush cytology from bile duct versus pancreatic duct.Gastrointest Endosc. 1999; 49: 322-327Abstract Full Text Full Text PDF PubMed Scopus (132) Google Scholar, 22Cotton P.B. Lehman G. Vennes J. et al.Endoscopic sphincterotomy complications and their management: an attempt at consensus.Gastrointest Endosc. 1991; 37: 383-393Abstract Full Text PDF PubMed Scopus (2445) Google Scholar, 23Tarnasky P. Cunningham J. Cotton P. et al.Pancreatic sphincter hypertension increases the risk of post-ERCP pancreatitis.Endoscopy. 1997; 29: 252-257Crossref PubMed Scopus (108) Google Scholar, 24Sherman S. Troiano F.P. Hawes R.H. et al.Sphincter of Oddi manometry: decreased risk of clinical pancreatitis with use of a modified aspirating catheter.Gastrointest Endosc. 1990; 36: 462-466Abstract Full Text PDF PubMed Scopus (166) Google Scholar, 25Rashdan A. Fogel E.L. Mchenry Jr, L. et al.Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.Clin Gastroenterol Hepatol. 2004; 2: 322-329Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar Although numerous mechanisms of post-ERCP pancreatitis have been suggested,1Freeman M.L. Nalini M. Guda M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar, 2Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1011) Google Scholar, 3Cheng C.L. Sherman S. Watkins J.L. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 2006; 101: 139-147Crossref PubMed Scopus (495) Google Scholar, 4Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2210) Google Scholar, 5Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 6Mehta S.N. Pavone E. Barkun J.S. et al.Predictors of post-ERCP complications in patients with suspected choledocholithiasis.Endoscopy. 1998; 30: 457-463Crossref PubMed Scopus (114) Google Scholar, 7Sherman S. Ruffolo T.A. Hawes R.H. et al.A prospective series with emphasis on the increased risk associates with sphincter of Oddi dysfunction and nondilated bile ducts.Gastroenterology. 1991; 101: 778-782Google Scholar, 8Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (487) Google Scholar, 9Elton E. Howell D.A. Parsons W.G. et al.Endoscopic pancreatic sphincterotomy: indications, outcome, and a safe stentless technique.Gastrointest Endosc. 1998; 47: 240-249Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar, 10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar, 11Tarnasky P.R. Palesch Y.Y. Cunningham J.T. et al.Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.Gastroenterology. 1998; 115: 1518-1524Abstract Full Text Full Text PDF PubMed Scopus (374) Google Scholar, 12Smithline A. Silverman W. Rogers D. et al.Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.Gastrointest Endosc. 1993; 39: 652-657Abstract Full Text PDF PubMed Scopus (191) Google Scholar, 13Singh P. Das A. Isenberg G. et al.Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.Gastrointest Endosc. 2004; 60: 544-550Abstract Full Text Full Text PDF PubMed Scopus (315) Google Scholar, 14Catalano M.F. Linder J.D. Chak A. et al.Endoscopic management of adenoma of the major duodenal papilla.Gastrointest Endosc. 2004; 59: 225-232Abstract Full Text Full Text PDF PubMed Scopus (293) Google Scholar, 15Tsuchiya T. Itoi T. Sofuni A. et al.A temporary inner unflanged 5Fr pancreatic duct stent to prevent post-ERCP pancreatitis A preliminary and single center randomized controlled trial study.Hep Bil Pancreatsurg. 2006; (in press)Google Scholar, 16Sherman S. Lehman G. Freeman M. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 1997; 92: 1639Google Scholar, 17Freeman M.L. Role of pancreatic stents in prevention of post-ERCP pancreatitis.J Pancreas. 2004; 5: 322-327PubMed Google Scholar, 18Fogel E.L. Eversman D. Jamidar P. et al.Sphincter of Oddi dysfunction: pancreaticobiliary sphincterotomy with pancreatic stent placement has a lower rate of pancreatitis than biliary sphincterotomy alone.Endoscopy. 2002; 34: 280-285Crossref PubMed Scopus (181) Google Scholar, 19Aizawa T. Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.Gastrointest Endosc. 2001; 54: 209123Abstract Full Text Full Text PDF Scopus (132) Google Scholar, 20Freeman M.L. Overby C. Qi D. Pancreatic stent insertion: consequence of failure and results of a modified technique to maximize success.Gastrointest Endosc. 2004; 59: 8-14Abstract Full Text Full Text PDF PubMed Scopus (177) Google Scholar, 21Vandervoort J. Soetikno R.M. Montes H. et al.Accuracy and complication rate of brush cytology from bile duct versus pancreatic duct.Gastrointest Endosc. 1999; 49: 322-327Abstract Full Text Full Text PDF PubMed Scopus (132) Google Scholar, 22Cotton P.B. Lehman G. Vennes J. et al.Endoscopic sphincterotomy complications and their management: an attempt at consensus.Gastrointest Endosc. 1991; 37: 383-393Abstract Full Text PDF PubMed Scopus (2445) Google Scholar, 23Tarnasky P. Cunningham J. Cotton P. et al.Pancreatic sphincter hypertension increases the risk of post-ERCP pancreatitis.Endoscopy. 1997; 29: 252-257Crossref PubMed Scopus (108) Google Scholar, 24Sherman S. Troiano F.P. Hawes R.H. et al.Sphincter of Oddi manometry: decreased risk of clinical pancreatitis with use of a modified aspirating catheter.Gastrointest Endosc. 1990; 36: 462-466Abstract Full Text PDF PubMed Scopus (166) Google Scholar, 25Rashdan A. Fogel E.L. Mchenry Jr, L. et al.Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.Clin Gastroenterol Hepatol. 2004; 2: 322-329Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar one of the most likely mechanisms is impaired drainage from the pancreatic duct caused by papillary edema and/or spasm of the sphincter of Oddi after the procedure.10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar, 11Tarnasky P.R. Palesch Y.Y. Cunningham J.T. et al.Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.Gastroenterology. 1998; 115: 1518-1524Abstract Full Text Full Text PDF PubMed Scopus (374) Google Scholar, 12Smithline A. Silverman W. Rogers D. et al.Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.Gastrointest Endosc. 1993; 39: 652-657Abstract Full Text PDF PubMed Scopus (191) Google Scholar, 13Singh P. Das A. Isenberg G. et al.Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.Gastrointest Endosc. 2004; 60: 544-550Abstract Full Text Full Text PDF PubMed Scopus (315) Google Scholar, 14Catalano M.F. Linder J.D. Chak A. et al.Endoscopic management of adenoma of the major duodenal papilla.Gastrointest Endosc. 2004; 59: 225-232Abstract Full Text Full Text PDF PubMed Scopus (293) Google Scholar, 19Aizawa T. Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.Gastrointest Endosc. 2001; 54: 209123Abstract Full Text Full Text PDF Scopus (132) Google Scholar, 22Cotton P.B. Lehman G. Vennes J. et al.Endoscopic sphincterotomy complications and their management: an attempt at consensus.Gastrointest Endosc. 1991; 37: 383-393Abstract Full Text PDF PubMed Scopus (2445) Google Scholar, 25Rashdan A. Fogel E.L. Mchenry Jr, L. et al.Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.Clin Gastroenterol Hepatol. 2004; 2: 322-329Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar As a countermeasure, some endoscopists have inserted a nasopancreatic drainage tube into the pancreatic duct9Elton E. Howell D.A. Parsons W.G. et al.Endoscopic pancreatic sphincterotomy: indications, outcome, and a safe stentless technique.Gastrointest Endosc. 1998; 47: 240-249Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar, 10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar or used a flanged pancreatic stent, not considering the possible advantages of spontaneous dislodgement.10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar, 11Tarnasky P.R. Palesch Y.Y. Cunningham J.T. et al.Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.Gastroenterology. 1998; 115: 1518-1524Abstract Full Text Full Text PDF PubMed Scopus (374) Google Scholar, 12Smithline A. Silverman W. Rogers D. et al.Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.Gastrointest Endosc. 1993; 39: 652-657Abstract Full Text PDF PubMed Scopus (191) Google Scholar, 13Singh P. Das A. Isenberg G. et al.Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.Gastrointest Endosc. 2004; 60: 544-550Abstract Full Text Full Text PDF PubMed Scopus (315) Google Scholar, 14Catalano M.F. Linder J.D. Chak A. et al.Endoscopic management of adenoma of the major duodenal papilla.Gastrointest Endosc. 2004; 59: 225-232Abstract Full Text Full Text PDF PubMed Scopus (293) Google Scholar, 19Aizawa T. Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.Gastrointest Endosc. 2001; 54: 209123Abstract Full Text Full Text PDF Scopus (132) Google Scholar, 20Freeman M.L. Overby C. Qi D. Pancreatic stent insertion: consequence of failure and results of a modified technique to maximize success.Gastrointest Endosc. 2004; 59: 8-14Abstract Full Text Full Text PDF PubMed Scopus (177) Google Scholar A pancreatic spontaneous dislodgement stent (PSDS) recently has become available commercially and has been reported to be effective in preventing post-ERCP pancreatitis.1Freeman M.L. Nalini M. Guda M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar, 15Tsuchiya T. Itoi T. Sofuni A. et al.A temporary inner unflanged 5Fr pancreatic duct stent to prevent post-ERCP pancreatitis A preliminary and single center randomized controlled trial study.Hep Bil Pancreatsurg. 2006; (in press)Google Scholar, 17Freeman M.L. Role of pancreatic stents in prevention of post-ERCP pancreatitis.J Pancreas. 2004; 5: 322-327PubMed Google Scholar, 18Fogel E.L. Eversman D. Jamidar P. et al.Sphincter of Oddi dysfunction: pancreaticobiliary sphincterotomy with pancreatic stent placement has a lower rate of pancreatitis than biliary sphincterotomy alone.Endoscopy. 2002; 34: 280-285Crossref PubMed Scopus (181) Google Scholar, 19Aizawa T. Ueno N. Stent placement in the pancreatic duct prevents pancreatitis after endoscopic sphincter dilation for removal of bile duct stones.Gastrointest Endosc. 2001; 54: 209123Abstract Full Text Full Text PDF Scopus (132) Google Scholar, 20Freeman M.L. Overby C. Qi D. Pancreatic stent insertion: consequence of failure and results of a modified technique to maximize success.Gastrointest Endosc. 2004; 59: 8-14Abstract Full Text Full Text PDF PubMed Scopus (177) Google Scholar, 25Rashdan A. Fogel E.L. Mchenry Jr, L. et al.Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.Clin Gastroenterol Hepatol. 2004; 2: 322-329Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar Pancreatic duct stents (PS) are classified into those with and without flanges on the pancreatic ductal side. The former is unlikely to dislodge naturally, and endoscopic removal often is necessary. As for the latter unflanged PS, the rate of natural dislodgement within a short period is high,1Freeman M.L. Nalini M. Guda M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar, 17Freeman M.L. Role of pancreatic stents in prevention of post-ERCP pancreatitis.J Pancreas. 2004; 5: 322-327PubMed Google Scholar, 25Rashdan A. Fogel E.L. Mchenry Jr, L. et al.Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.Clin Gastroenterol Hepatol. 2004; 2: 322-329Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar and re-insertion of an endoscope for removal generally is unnecessary. We first conducted a preliminary single-center, randomized, controlled study to prospectively evaluate the efficacy of a temporary unflanged PS in preventing post-ERCP pancreatitis.15Tsuchiya T. Itoi T. Sofuni A. et al.A temporary inner unflanged 5Fr pancreatic duct stent to prevent post-ERCP pancreatitis A preliminary and single center randomized controlled trial study.Hep Bil Pancreatsurg. 2006; (in press)Google Scholar Based on the encouraging results from our preliminary study, we conducted a randomized, controlled, multicenter study to evaluate whether placement of a PSDS prevents pancreatitis after ERCP-related procedures. This randomized, controlled, multicenter trial was executed between June and November 2005 at 6 large endoscopic units performing more than 400 ERCPs each per year. We planned to include 220 patients to allow for patients being excluded. The sample size calculations indicated that approximately 150 patients would be required in each study group to detect a decrease in the incidence of post-ERCP pancreatitis from 15% to 5% (α = .05, β = .2; 2-tailed test).1Freeman M.L. Nalini M. Guda M. Prevention of post-ERCP pancreatitis: a comprehensive review.Gastrointest Endosc. 2004; 59: 845-864Abstract Full Text Full Text PDF PubMed Scopus (403) Google Scholar, 2Freeman M.L. DiSario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1011) Google Scholar, 3Cheng C.L. Sherman S. Watkins J.L. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 2006; 101: 139-147Crossref PubMed Scopus (495) Google Scholar, 4Freeman M.L. Nelson D.B. Sherman S. et al.Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2210) Google Scholar, 5Masci E. Toti G. Mariani A. et al.Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar, 6Mehta S.N. Pavone E. Barkun J.S. et al.Predictors of post-ERCP complications in patients with suspected choledocholithiasis.Endoscopy. 1998; 30: 457-463Crossref PubMed Scopus (114) Google Scholar, 7Sherman S. Ruffolo T.A. Hawes R.H. et al.A prospective series with emphasis on the increased risk associates with sphincter of Oddi dysfunction and nondilated bile ducts.Gastroenterology. 1991; 101: 778-782Google Scholar, 8Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (487) Google Scholar, 9Elton E. Howell D.A. Parsons W.G. et al.Endoscopic pancreatic sphincterotomy: indications, outcome, and a safe stentless technique.Gastrointest Endosc. 1998; 47: 240-249Abstract Full Text Full Text PDF PubMed Scopus (144) Google Scholar, 10Fazel A. Quadri A. Catalano M.F. et al.Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.Gastrointest Endosc. 2003; 57: 291-294Abstract Full Text Full Text PDF PubMed Scopus (295) Google Scholar, 11Tarnasky P.R. Palesch Y.Y. Cunningham J.T. et al.Pancreatic stenting prevents pancreatitis after biliary sphincterotomy in patients with sphincter of Oddi dysfunction.Gastroenterology. 1998; 115: 1518-1524Abstract Full Text Full Text PDF PubMed Scopus (374) Google Scholar, 12Smithline A. Silverman W. Rogers D. et al.Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.Gastrointest Endosc. 1993; 39: 652-657Abstract Full Text PDF PubMed Scopus (191) Google Scholar, 13Singh P. Das A. Isenberg G. et al.Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.Gastrointest Endosc. 2004; 60: 544-550Abstract Full Text Full Text PDF PubMed Scopus (315) Google Scholar, 14Catalano M.F. 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