Precut Papillotomy Versus Persistence in Difficult Biliary Cannulation: A Prospective Randomized Trial

Background and Study Aims: Failed biliary cannulation occurs in up to 10 % of patients undergoing ERCP. There is some controversy as to the safety and efficacy of using precut techniques to achieve biliary cannulation in difficult cases. To date, no randomized trial has compared the success and complication rates of precut with the rates for persistence when biliary cannulation is difficult. The aim of this study was to compare the success rates and complication rates of precut with the success rates and complication rates of persistence in cases of difficult biliary cannulation.
Patients and Methods: Patients without prior sphincterotomy who required biliary cannulation were screened. A “difficult biliary cannulation” was arbitrarily defined as failed cannulation after 12 minutes. These patients were then randomized to continue treatment by needle-knife cut over the roof of the papilla or by persistence with a non-wire-guided, single-lumen papillotome. “Primary” success was defined as deep cannulation within 15 minutes of randomization. Primary and final success rates and complication rates within 30 days after ERCP were compared.
Results: Over a 38-month period a total of 642 patients were screened. Patients in whom biliary cannulation was successful within a time period of 12 minutes or less formed the reference group (n = 580). The remainder of the patients were randomly assigned to the “precut” arm (n = 32) or to the “persistence” arm (n = 30). Primary success rates and complication rates were similar in the precut and persistence arms (75 % and 4 % respectively for the precut arm vs. 73 % and 9 % for the persistence arm). The final successful cannulation rate in the entire group of 642 patients was 99.5 %.
Conclusions: In experienced hands, precut papillotomy and persistence in cannulation are equally effective in cases of difficult cannulation, with a similar complication rate.

References

• 1 Freeman M L, Nelson D B, Sherman S. et al . Complications of endoscopic biliary sphincterotomy.  N Engl J Med. 1996;  335 909-918
• 2 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
• 3 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
• 4 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
• 5 Vandervoort J, Soetikno R M, Tham T C. et al . Risk factors for complications after performance of ERCP.  Gastrointest Endosc. 2002;  56 652-656
• 6 Freeman M L. Adverse events and success of ERCP.  Gastrointest Endosc. 2002;  56 S273-S282
• 7 Cohen S, Bacon B R, Berlin J A. et al . ERCP for diagnosis and therapy. National Institutes of Health State-of-the-Science Conference Statement; 2002 January 14-16.  Gastrointest Endosc. 2002;  56 803-809
• 8 Cortas G A, Mehta S N, Abraham N S, Barkun A N. Selective cannulation of the common bile duct: a prospective randomized trial comparing standard catheters with sphincterotomes.  Gastrointest Endosc. 1999;  50 775-779
• 9 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
• 10 Freeman M L. Towards improving outcomes of ERCP.  Gastrointest Endosc. 1998;  48 96-102
• 11 Dhir V, Mallath M K. Is precut papillotomy guilty as accused? [Letter].  Gastrointest Endosc. 1999;  50 143-144
• 12 Neoptolemos J P, Shaw D E, Carr-Locke D L. A multivariate analysis of preoperative risk factors in patients with common bile duct stones: implications for treatment.  Ann Surg. 1989;  209 157-161
• 13 Slot W B, Schoeman M N, Disario J A. et al . Needle-knife sphincterotomy as a precut procedure: a retrospective evaluation of efficacy and complications.  Endoscopy. 1996;  28 334-339
• 14 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
• 15 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
• 16 Leemis L M, Trivedi K S. A comparison of approximate interval estimators for the Bernoulli parameter.  Am Stat. 1996;  50 63-68
• 17 Newcombe R G. Interval estimation for the difference between independent proportions: comparison of 11 methods.  Stat Med. 1998;  17 873-890
• 18 Binmoeller K F, Seifert H, Gerke H. et al . Papillary roof incision using the Erlangen-type precut papillotome to achieve bile duct cannulation.  Gastrointest Endosc. 1996;  44 689-695
• 19 Huibregtse K, Katon R M, Tytgat G NJ. Precut papillotomy via fine needle-knife papillotomy: a safe and effective technique.  Gastrointest Endosc. 1986;  32 403-405
• 20 Cotton P B. Precut papillotomy: a risky technique for experts only.  Gastrointest Endosc. 1989;  35 578-579
• 21 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
• 22 Tarnasky 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 1518-1524
• 23 Fazel A, Quadri A, Catalano M F. et al . Does a pancreatic duct stent prevent post-ERCP pancreatitis? A prospective randomized study.  Gastrointest Endosc. 2003;  57 291-294