Transpancreatic biliary sphincterotomy versus double guidewire in difficult biliary cannulation: a randomized controlled trial

Abstract

Background Difficult biliary cannulation in endoscopic retrograde cholangiopancreatography (ERCP) increases the risk of post-ERCP pancreatitis (PEP). The purpose of this prospective, randomized, multicenter study was to compare two advanced rescue methods, transpancreatic biliary sphincterotomy (TPBS) and a double-guidewire (DGW) technique, in difficult common bile duct (CBD) cannulation.

Methods Patients with native papilla and planned CBD cannulation were recruited at eight Scandinavian hospitals. An experienced endoscopist attempted CBD cannulation with wire-guided cannulation. If the procedure fulfilled the definition of difficult cannulation and a guidewire entered the pancreatic duct, randomization to either TPBS or to DGW was performed. If the randomized method failed, any method available was performed. The primary end point was the frequency of PEP and the secondary end points included successful cannulation with the randomized method.

Results In total, 1190 patients were recruited and 203 (17.1 %) were randomized according to the study protocol (TPBS 104 and DGW 99). PEP developed in 14/104 patients (13.5 %) in the TPBS group and 16/99 patients (16.2 %) in the DGW group (P = 0.69). No difference existed in PEP severity between the groups. The rate of successful deep biliary cannulation was significantly higher with TPBS (84.6 % [88/104]) than with DGW (69.7 % [69/99]; P = 0.01).

Conclusions In difficult biliary cannulation, there was no difference in PEP rate between TPBS and DGW techniques. TPBS is a good alternative in cases of difficult cannulation when the guidewire is in the pancreatic duct.

Publikationsverlauf

Eingereicht: 17. Mai 2020

Angenommen nach Revision: 27. Oktober 2020

Artikel online veröffentlicht:
13. Januar 2021

• References

• 1 Testoni PA, Mariani A, Aabakken L. et al. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2016; 48: 657-683
• 2 Dumonceau J-M, Andriulli A, Elmunzer BJ. et al. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – updated June 2014. Endoscopy 2014; 46: 799-815
• 3 Halttunen J, Meisner S, Aabakken L. et al. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol 2014; 49: 752-758
• 4 Testoni PA, 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
• 5 Halttunen J, Keranen I, Udd M. et al. Pancreatic sphincterotomy versus needle knife precut in difficult biliary cannulation. Surg Endosc 2009; 23: 745-749
• 6 Cotton PB, Lehman G, Vennes J. et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
• 7 Goff JS. Long-term experience with the transpancreatic sphincter pre-cut approach to biliary sphincterotomy. Gastrointest Endosc 1999; 50: 642-645
• 8 Yoo YW, Cha SW, Lee WC. et al. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol 2013; 19: 108-114
• 9 Angsuwatcharakon P, Rerknimitr R, Ridtitid W. et al. Success rate and cannulation time between precut sphincterotomy and double-guidewire technique in truly difficult biliary cannulation. J Gastroenterol Hepatol 2012; 27: 356-361
• 10 Herreros de Tejada A, Calleja JL, Diaz G. et al. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest Endosc 2009; 70: 700-709
• 11 Ito K, Fujita N, Noda Y. et al. Pancreatic guidewire placement for achieving selective biliary cannulation during endoscopic retrograde cholangio-pancreatography. World J Gastroenterol 2008; 14: 5595-5600
• 12 Hennekens CH, Buring SE, Mayrent SL. Epidemiology in medicine. Boston, USA: Little, Brown & Co; 1987
• 13 Tse F, Yuan Y, Moayyedi P. et al. Double-guidewire technique in difficult biliary cannulation for the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis. Endoscopy 2017; 49: 15-26
• 14 Catalano MF, Linder JD, Geenen JE. Endoscopic transpancreatic papillary septotomy for inaccessible obstructed bile ducts: comparison with standard pre-cut papillotomy. Gastrointest Endosc 2004; 60: 557-561
• 15 Lee YJ, Park YK, Lee MJ. et al. Different strategies for transpancreatic septotomy and needle knife infundibulotomy due to the presence of unintended pancreatic cannulation in difficult biliary cannulation. Gut Liver 2015; 9: 534-539
• 16 Sugiyama H, Tsuyuguchi T, Sakai Y. et al. Transpancreatic precut papillotomy versus double-guidewire technique in difficult biliary cannulation: prospective randomized study. Endoscopy 2018; 50: 33-39
• 17 Zang J, Zhang C, Gao J. Guidewire-assisted transpancreatic sphincterotomy for difficult biliary cannulation: a prospective randomized controlled trial. Surg Laparosc Endosc Percutan Tech 2014; 24: 429-433
• 18 Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004; 59: 845-864
• 19 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
• 20 Kapral C, Mühlberger A, Wewalka F. et al. Quality assessment of endoscopic retrograde cholangiopancreatography. Eur J Gastroenterol Hepatol 2012; 24: 1447-1454
• 21 Parekh PJ, Majithia R, Sikka SK. et al. The “Scope” of post-ERCP pancreatitis. Mayo Clin Proc 2017; 92: 434-448
• 22 Dumonceau JM, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-149
• 23 Cheng CL, Sherman S, Watkins JL. et al. Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol 2006; 101: 139-147
• 24 Lee H, Cho CM, Heo J. et al. Impact of hospital volume and the experience of the endoscopist on adverse events related to endoscopic retrograde cholangiopancreatography: a prospective observational study. Gut Liver 2020; 14: 257-264
• 25 Freeman ML, DiSario JA, Nelson DB. et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-434
• 26 Keswani RN, Qumseya BJ, O’Dwyer LC. et al. Association between endoscopist and center endoscopic retrograde cholangiopancreatography volume with procedure success and adverse outcomes: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2017; 15: 1866-1875
• 27 Goff JS. Common bile duct pre-cut sphincterotomy: transpancreatic sphincter approach. Gastrointest Endosc 1995; 41: 502-505
• 28 Kahaleh M, Tokar J, Mullick T. et al. Prospective evaluation of pancreatic sphincterotomy as a precut technique for biliary cannulation. Clin Gastroenterol Hepatol 2004; 2: 971-977
• 29 Dumonceau JM, Deviere J, Cremer M. A new method of achieving deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography. Endoscopy 1998; 30: S80
• 30 Gronroos JM, Vihervaara H, Gullichsen R. et al. Double-guidewire-assisted biliary cannulation: experiences from a single tertiary referral center. Surg Endosc 2011; 25: 1599-1602
• 31 Lee YS, Cho CM, Cho KB. et al. Difficult biliary cannulation from the perspective of post-endoscopic retrograde cholangiopancreatography pancreatitis: identifying the optimal timing for the rescue cannulation technique. Gut Liver 2020; DOI: 10.5009/gnl19304.
• 32 Sotoudehmanesh R, Ali-Asgari A, Khatibian M. et al. Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial. Endoscopy 2019; 51: 915-921
• 33 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 Digestive Endoscopy Study Group for ERCP. Gastrointest Endosc 2019; 90: 957-963
• 34 Pécsi D, Farkas N, Hegyi P. et al. Transpancreatic sphincterotomy is effective and safe in expert hands on the short term. Dig Dis Sci 2019; 64: 2429-2444
• 35 Koskensalo V, Udd M, Rainio M. et al. Transpancreatic biliary sphincterotomy for biliary access is safe also on a long-term scale. Surg Endosc 2020; DOI: 10.1007/s00464-019-07364-y.