Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos)

      Background and Aims

      Precut sphincterotomy, usually performed after prolonged and failed cannulation, is considered a risk factor for post-ERCP pancreatitis (PEP). There are limited studies on primary needle-knife precut for the prevention of PEP. The aim of this study was to assess the safety and efficacy of primary precut.


      A randomized controlled trial was conducted in a tertiary care setting on patients who underwent ERCP. Patients were randomized to very early precut (group A, precut after 2 failed attempts of wire-guided sphincterotome cannulation) and primary precut (group B, direct needle-knife precut). All procedures were done by an experienced endoscopist. The primary outcome of the study was to compare the incidence of PEP between the 2 groups.


      Three hundred three patients were randomized to group A (n = 152, age 48.2 ± 15.4 years, 61 men) and group B (n = 151, age 46.7 ± 13.8 years, 65 men). There was no significant difference in baseline characteristics and indications for ERCP between the 2 groups. Development of PEP (5.2% vs .67%; P = .04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; P = .01) were lower in group B compared with group A. The bile duct cannulation time (13.8 ± 2.2 vs 7.2 ± 1.7 minutes; P = .001) was lower in group B, whereas the overall cannulation success rate (98% vs 98.6%; P = 1.0) was similar in both the groups.


      Primary precut by an experienced endoscopist results in low risk of PEP. (Clinical trial registration number: CTRI/2017/08/009510.)


      CBD (common bile duct), PEP (post-ERCP pancreatitis)
      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


        • Larkin C.J.
        • Huibregtse K.
        Precut sphincterotomy: indications, pitfalls and complications.
        Curr Gastroenterol Rep. 2001; 3: 147-153
        • Bailey A.A.
        • Bourke M.J.
        • Williams S.J.
        • et al.
        A prospective randomized trial of cannulation technique in ERCP: effects on technical success and post-ERCP pancreatitis.
        Endoscopy. 2008; 40: 296-301
        • Williams E.J.
        • Taylor S.
        • Fairclough P.
        • et al.
        Are we meeting the standards set for endoscopy? Results of a large-scale prospective survey of endoscopic retrograde cholangiopancreatography practice.
        Gut. 2007; 56: 821-829
        • Freeman M.L.
        • Guda N.M.
        ERCP cannulation: a review of reported techniques.
        Gastrointest Endosc. 2005; 61: 112-125
        • 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
        • 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
        • Dumonceau J.M.
        • Andriulli A.
        • Elmunzer B.J.
        • et al.
        Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) guideline—updated June 2014.
        Endoscopy. 2014; 46: 799-815
        • Masci E.
        • Mariani A.
        • Curioni S.
        • et al.
        Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis.
        Endoscopy. 2003; 35: 830-834
        • Loperfido S.
        • Angelini G.
        • Benedetti G.
        • et al.
        Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.
        Gastrointest Endosc. 1998; 48: 1-10
        • 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
        • Wang P.
        • Li Z.S.
        • Liu F.
        • et al.
        Risk factors for ERCP-related complications: a prospective multicenter study.
        Am J Gastroenterol. 2009; 104: 31-40
        • Testoni P.A.
        • Mariani A.
        • Giussani A.
        • et al.
        Risk factors for post-ERCP pancreatitis in high and low-volume centers and among expert and non-expert operators: a prospective multicenter study.
        Am J Gastroenterol. 2010; 105: 1753-1761
        • Freeman M.L.
        • Nelson D.B.
        • Sherman S.
        • et al.
        Complications of biliary sphincterotomy.
        N Eng J Med. 1996; 335: 909-918
        • Vandervoort J.
        • Soetikno R.M.
        • Tham T.C.
        • et al.
        Risk factor for complications after performance of ERCP.
        Gastrointest Endosc. 2002; 56: 652-656
        • 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
        • Cennamo V.
        • Fuccio L.
        • Repici A.
        • et al.
        Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study.
        Gastrointest Endosc. 2009; 69: 473-479
        • Kaffes A.J.
        • Sriram P.V.J.
        • Rao G.V.
        • et al.
        Early institution of precutting for difficult biliary cannulation: a prospective study comparing conventional vs a modified technique.
        Gastrointest Endosc. 2005; 62: 669-674
        • Mariani A.
        • Di Leo M.
        • Giardullo N.
        • et al.
        Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial.
        Endoscopy. 2016; 48: 530-535
        • Testoni P.A.
        • Giussani A.
        • Vailati C.
        • et al.
        Precut sphincterotomy, repeated cannulation and post-ERCP pancreatitis in patients with bile duct stone disease.
        Dig Liver Dis. 2011; 43: 792-796
        • De Weerth A.
        • Seitz U.
        • Zhong Y.
        • et al.
        Primary precutting versus conventional over the wire sphincterotomy for bile duct access: a prospective randomized study.
        Endoscopy. 2006; 38: 1235-1240
        • Khatibian M.
        • Sotoudehmanesh R.
        • Ali-Asgari A.
        • et al.
        Needle-knife fistulotomy versus standard method for cannulation of common bile duct: a randomized controlled trial.
        Arch Iran Med. 2008; 11: 16-20
        • Jang S.I.
        • Kim D.U.
        • Cho G.H.
        • et al.
        Primary needle-knife fistulotomy versus conventional cannulation method in a high-risk cohort of post-endoscopic retrograde cholangiopancreatography pancreatitis.
        Am J Gastroenterol. 2020; 115: 616-624
        • Haraldsson E.
        • Lundell L.
        • Swahn F.
        • et al.
        Endoscopic classification of the papilla of Vater. Results of an inter- and intra-observer agreement study.
        United Eur Gastroenterol J. 2017; 5: 504-510
        • Chandrasekhara V.
        • Khashab M.A.
        • Muthusamy V.R.
        • et al.
        Adverse events associated with ERCP.
        Gastrointest Endosc. 2017; 85: 32-47
        • 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
        • Kochar B.
        • Akshintala V.S.
        • Afghani E.
        • et al.
        Incidence, severity and mortality of post-ERCP pancreatitis: a systemic review by using randomized, controlled trials.
        Gastrointest Endosc. 2015; 81: 143-149
        • Rollhauser C.
        • Johnson M.
        • Al-Kawas F.H.
        Needle knife papillotomy: a helpful and safe adjunct to endoscopic retrograde cholangiopancreatography in a selected population.
        Endoscopy. 1998; 30: 691-696
        • Harewood G.C.
        • Baron T.H.
        An assessment of the learning curve for precut billiary sphincterotomy.
        Am J Gasteroenterol. 2002; 97: 1708-1712
        • Haraldsson E.
        • Kylanpaa L.
        • Gronroos J.
        • et al.
        Macroscopic appearance of the major duodenal papilla influences bile duct cannulation: a prospective multicenter study by the Scandinavian Association for the Digestive Study Group for ERCP.
        Gastrointest Endosc. 2019; 90: 957-963
        • Swan M.P.
        • Alexander S.
        • Moss A.
        • et al.
        Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation.
        Clin Gastroenterol Hepatol. 2013; 11: 430-438
        • Katsinelos P.
        • Gkagkalis S.
        • Chatzimavroudis G.
        • et al.
        Comparison of three types of precut technique to achieve common bile duct cannulation: a retrospective analysis of 274 cases.
        Di Dis Sci. 2012; 57: 3286-3292
        • Elmunzer B.J.
        • Scheiman J.M.
        • Lehman G.A.
        • et al.
        A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.
        N Engl J Med. 2012; 366: 1414-1422
        • Mazaki T.
        • Mado K.
        • Masuda H.
        • et al.
        Prophylactic pancreatic stent placement and post-ERCP pancreatitis: an updated meta-analysis.
        J Gastroenterol. 2014; 49: 343-355

      Linked Article

      • Primary precut sphincterotomy to reduce post-ERCP pancreatitis
        Gastrointestinal EndoscopyVol. 93Issue 1
        • Preview
          We read with great interest the article by Maharshi et al1 on a randomized controlled trial (RCT) about early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis (PEP). In their study they showed that primary precut in comparison with early precut by an experienced endoscopist results in a lower risk of PEP, with similar overall rates of cannulation success. We would like to applaud the authors because this RCT stands apart, inasmuch as no published study is available, to our knowledge, in which such comparisons have been made.
        • Full-Text
        • PDF
      • Primary precut sphincterotomy: a call for large, multicenter trials
        Gastrointestinal EndoscopyVol. 96Issue 1
        • Preview
          We read the recent article by Maharshi and Sharma1 with interest. They performed a single-center randomized controlled trial assessing the rate of post-ERCP pancreatitis (PEP) with very early precut sphincterotomy compared with primary precut sphincterotomy. We would like to highlight our concerns.
        • Full-Text
        • PDF
      • Precut biliary sphincterotomy in ERCP: Don’t reach for the needle-knife quite so fast!
        Gastrointestinal EndoscopyVol. 93Issue 3
        • Preview
          The most essential quality metrics in ERCP are high technical success for biliary access and relatively low adverse event rates.1-6 Biliary access rates >90% and adverse event rates <5% are now considered the community standard and can be achieved by advanced endoscopy fellows with adequate training.1-4,7-10 However, expert centers routinely report initial ERCP access rates of >95% (often 98% or better).2,5 One large ERCP quality network reported 96% technical success incorporating all techniques and even higher rates for high-volume endoscopists (>200+ annually), with minimal adverse events.
        • Full-Text
        • PDF