Does leaving a main pancreatic duct stent in place reduce the incidence of precut biliary sphincterotomy–associated pancreatitis? A randomized, prospective study

Published:October 22, 2012DOI:


      Pancreatitis is the most common major complication of ERCP and precut endoscopic sphincterotomy (ES). Prophylactic pancreatic duct (PD) stent placement has been shown to reduce the incidence and severity of post-ERCP pancreatitis (PEP) in high-risk settings.


      To determine whether leaving a main PD stent in place after precut ES would reduce the incidence and severity of PEP.


      Single-center, randomized, prospective study.


      Tertiary care ERCP referral center.


      Consecutive patients who underwent ERCP with a clear indication for biliary access and standard biliary ES whereby free cannulation of the bile duct was not possible and precut ES was undertaken.


      When free bile duct cannulation for ES was not possible and selective PD cannulation was achieved, a PD stent was placed. Using the PD stent as a guide, we used a needle-knife sphincterotome to perform precut ES. The patients were then randomized to either leaving the PD stent in place for 7 to 10 days (stent group) or immediate removal after the procedure (stent removed group). The remaining patients who did not undergo selective PD cannulation and stent placement were not randomized (no stent group) and had a free-hand needle-knife ES performed.

      Main Outcome Measurements

      Patients were prospectively followed for the development of complications. Standardized criteria were used to diagnose and grade the severity of PEP.


      A total of 151 patients were enrolled. The groups were similar with regard to patient demographics and patient and procedure risk factors for PEP. The overall incidence of PEP was 13.2% (20/151). It occurred in 4.3% (2/46), 21.3% (10/47), and 13.8% (8/58) of patients in the stent, stent removed, and no stent groups, respectively. The stent group had a significantly lower frequency and severity of PEP compared with the stent removed group (4.3% vs 21.3%; P = .027 for frequency and 0% vs 12.8%; P = .026 for moderate and severe pancreatitis).


      Single center. Randomization scheme not optimal.


      These data suggest that placing and maintaining a PD stent for needle-knife precut ES reduces the frequency and severity of postprocedure pancreatitis.


      ES (endoscopic sphincterotomy), PD (pancreatic duct), PEP (post-ERCP pancreatitis), SOD (sphincter of Oddi dysfunction)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Abdel Aziz A.M.
        • Lehman G.A.
        Pancreatitis after endoscopic retrograde cholangio-pancreatography.
        World J Gastroenterol. 2007; 13: 2655-2668
        • Freeman M.L.
        • Nelson D.B.
        • Sherman S.
        • et al.
        Complications of endoscopic biliary sphincterotomy.
        N Engl J Med. 1996; 335: 909-918
        • Cheng C.L.
        • Sherman S.
        • Watkins J.L.
        • et al.
        Risk factors for post-ERCP pancreatitis: a prospective multicenter study.
        Am J Gastroenterol. 2006; 101: 139-147
        • Freeman M.L.
        • DiSario J.A.
        • Nelson D.B.
        • et al.
        Risk factors for post-ERCP pancreatitis: a prospective, multicenter study.
        Gastrointest Endosc. 2001; 54: 425-434
        • Andriulli A.
        • Loperfido S.
        • Napolitano G.
        • et al.
        Incidence rates of post-ERCP complications: a systematic survey of prospective studies.
        Am J Gastroenterol. 2007; 102: 1781-1788
        • Freeman M.L.
        Pancreatic stents for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis.
        Clin Gastroenterol Hepatol. 2007; 5: 1354-1365
        • Freeman M.L.
        • Overby C.
        • Qi D.
        Pancreatic stent insertion: consequences of failure and results of a modified technique to maximize success.
        Gastrointest Endosc. 2004; 59: 8-14
        • Freeman M.L.
        • Guda N.M.
        Prevention of post-ERCP pancreatitis: a comprehensive review.
        Gastrointest Endosc. 2004; 59: 845-864
        • Fazel A.
        • Quadri A.
        • Catalano M.F.
        • et al.
        Does a pancreatic duct stent prevent post-ERCP pancreatitis?.
        Gastrointest Endosc. 2003; 57: 291-294
        • Fogel 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: 280-285
        • Saad A.M.
        • Fogel E.L.
        • McHenry L.
        • et al.
        Pancreatic duct stent placement prevents post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction but normal manometry results.
        Gastrointest Endosc. 2008; 67: 255-261
        • Smithline 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: 652-657
        • Harewood G.C.
        • Pochron N.L.
        • Gostout C.J.
        Prospective, randomized, controlled trial of prophylactic pancreatic stent placement for endoscopic snare excision of the duodenal ampulla.
        Gastrointest Endosc. 2005; 62: 367-370
        • Vandervoort 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: 322-327
        • Aizawa 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: 209-213
        • Choudhary A.
        • Bechtold M.L.
        • Arif M.
        • et al.
        Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review.
        Gastrointest Endosc. 2011; 73: 275-282
        • Sofuni A.
        • Maguchi H.
        • Mukai T.
        • et al.
        Endoscopic pancreatic duct stents reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients.
        Clin Gastroenterol Hepatol. 2011; 9: 851-858
        • Kasmin F.E.
        • Cohen D.
        • Batra S.
        • et al.
        Needle-knife sphincterotomy in a tertiary referral center: efficacy and complications.
        Gastrointest Endosc. 1996; 44: 48-53
        • Masci E.
        • Mariani A.
        • Curioni S.
        • et al.
        Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis.
        Endoscopy. 2003; 35: 830-834
        • Masci E.
        • Toti G.
        • Mariani A.
        • et al.
        Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.
        Am J Gastroenterol. 2001; 96: 417-423
        • Cotton P.B.
        • Lehman G.
        • Vennes J.
        • et al.
        Endoscopic sphincterotomy complications and their management: an attempt at consensus.
        Gastrointest Endosc. 1991; 37: 383-393
        • Cortas G.A.
        • Mehta S.N.
        • Abraham N.S.
        • et al.
        Selective cannulation of the common bile duct: a prospective randomized trial comparing standard catheters with sphincterotomes.
        Gastrointest Endosc. 1999; 50: 775-779
        • Schwacha H.
        • Allgaier H.P.
        • Deibert P.
        • et al.
        A sphincterotome-based technique for selective transpapillary common bile duct cannulation.
        Gastrointest Endosc. 2000; 52: 387-391
        • Dowsett J.F.
        • Polydorou A.A.
        • Vaira D.
        • et al.
        Needle knife papillotomy: how safe and how effective?.
        Gut. 1990; 31: 905-908
        • Foutch P.G.
        A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy.
        Gastrointest Endosc. 1995; 41: 25-32
        • Gullichsen R.
        • Lavonius M.
        • Laine S.
        • et al.
        Needle-knife assisted ERCP.
        Surg Endosc. 2005; 19: 1243-1245
        • Halttunen J.
        • Keränen I.
        • Udd M.
        • et al.
        Pancreatic sphincterotomy versus needle knife precut in difficult biliary cannulation.
        Surg Endosc. 2009; 23: 745-749
        • Tang S.J.
        • Haber G.B.
        • Kortan P.
        • et al.
        Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial.
        Endoscopy. 2005; 37: 58-65
        • Lee J.K.
        • Park J.K.
        • Yoon W.J.
        • et al.
        Risk for post-ERCP pancreatitis after needle knife precut sphincterotomy following repeated cannulation attempts.
        J Clin Gastroenterol. 2007; 41: 427-431
        • Katsinelos P.
        • Mimidis K.
        • Paroutoglou G.
        • et al.
        Needle-knife papillotomy: a safe and effective technique in experienced hands.
        Hepatogastroenterology. 2004; 51: 349-352
        • Cheon Y.K.
        • Cho K.B.
        • Watkins J.L.
        • et al.
        Frequency and severity of post-ERCP pancreatitis correlated with extent of pancreatic ductal opacification.
        Gastrointest Endosc. 2007; 65: 385-393
        • Tarnasky P.R.
        Mechanical prevention of post-ERCP pancreatitis by pancreatic stents: results, techniques, and indications.
        JOP. 2003; 4: 58-67
        • Varadarajulu S.
        • Wilcox C.M.
        Randomized trial comparing needle-knife and pull-sphincterotome techniques for pancreatic sphincterotomy in high-risk patients.
        Gastrointest Endosc. 2006; 64: 716-722
        • Rashdan A.
        • Fogel E.L.
        • McHenry Jr, L.
        • et al.
        Improved stent characteristics for prophylaxis of post-ERCP pancreatitis.
        Clin Gastroenterol Hepatol. 2004; 2: 322-329