Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial

Alberto Mariani; Milena Di Leo; Nicola Giardullo; Antonella Giussani; Mario Marini; Federico Buffoli; Livio Cipolletta; Franco Radaelli; Paolo Ravelli; Giovanni Lombardi; Vittorio D’Onofrio; Raffaele Macchiarelli; Elena Iiritano; Marco Le Grazie; Giuseppe Pantaleo; Pier Alberto Testoni

doi:10.1055/s-0042-102250

Endoscopy, Inhaltsverzeichnis

Endoscopy 2016; 48(06): 530-535
DOI: 10.1055/s-0042-102250

Original article

Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial

Alberto Mariani

¹Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy

,

Milena Di Leo

¹Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy

,

Nicola Giardullo

²Gastroenterology and Gastrointestinal Endoscopy Unit, S.G. Moscati Hospital, Avellino, Italy

,

Antonella Giussani

¹Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy

,

Mario Marini

³Gastroenterology Unit, A.O.U.S. Policlinico S.Maria alle Scotte, Siena, Italy

,

Federico Buffoli

⁴Digestive Endoscopy and Gastroenterology Unit, A.O. Istituti Ospitalieri di Cremona, Italy

,

Livio Cipolletta

⁵Gastroenterology, Maresca Hospital, Torre del Greco, Italy

,

Franco Radaelli

⁶Division of Gastroenterology, Valduce Hospital, Como, Italy

,

Paolo Ravelli

⁷Digestive Endoscopy Unit, Department of Gastroenterology, Papa Giovanni XXIII Hospital, Bergamo, Italy

,

Giovanni Lombardi

⁸Digestive Endoscopy Unit, A. Cardarelli Hospital, Napoli, Italy

,

Vittorio D’Onofrio

²Gastroenterology and Gastrointestinal Endoscopy Unit, S.G. Moscati Hospital, Avellino, Italy

,

Raffaele Macchiarelli

³Gastroenterology Unit, A.O.U.S. Policlinico S.Maria alle Scotte, Siena, Italy

,

Elena Iiritano

⁴Digestive Endoscopy and Gastroenterology Unit, A.O. Istituti Ospitalieri di Cremona, Italy

,

Marco Le Grazie

¹Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy

,

Giuseppe Pantaleo

⁹UniSR-Social.Lab (Research Methods), San Raffaele University of Milan, Faculty of Psychology, Milan, Italy

,

Pier Alberto Testoni

¹Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy

› Institutsangaben

Abstract

Background and study aim: Precut sphincterotomy is a technique usually employed for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of bile duct disease. It is a validated risk factor for post-ERCP pancreatitis (PEP), but it is not clear whether the risk is related to the technique itself or to the repeated biliary cannulation attempts preceding it. The primary aim of the study was to assess the incidence of PEP in early precut compared with the standard technique in patients with difficult biliary cannulation. Secondary aims were to compare complications and cannulation success.

Patients and methods: In this prospective, multicenter, randomized, clinical trial, patients who were referred for therapeutic biliary ERCP and difficult biliary cannulation were randomized to early precut (Group A) or repeated papillary cannulation attempts followed, in cases of failure, by late precut (Group B). PEP was defined as the onset of upper abdominal pain associated with an elevation in serum pancreatic enzymes of at least three times the normal level at more than 24 hours after the procedure. No rectal indomethacin or diclofenac was used for prevention of PEP.

Results: A total of 375 patients were enrolled. PEP developed in 10 of the 185 patients (5.4 %) in Group A and 23 of the 190 (12.1 %) in Group B (odds ratio [OR] 0.35; 95 % confidence interval [CI] 0.16 – 0.78). The incidence of PEP was significantly lower in the early precut group (10/185, 5.4 %) than in the delayed precut subgroup (19/135 [14.1 %]; OR 0.42, 95 %CI 0.17 – 1.07). There were no differences in biliary cannulation success rates, bleeding, perforation, and cholangitis.

Conclusions: In patients with difficult biliary cannulation, early precut is an effective technique and can significantly reduce the incidence of PEP. Repeated biliary cannulation attempts are a real risk factor for this complication.

Volltext

Referenzen

References
1 Bailey AA, Bourke MJ, Williams SJ et al. A prospective randomized trial of cannulation technique in ERCP: effects on technical success and post-ERCP pancreatitis. Endoscopy 2008; 40: 296-301
2 Williams EJ, Taylor S, Fairclough P et al. Are we meeting the standards set for endoscopy? Results of a large-scale prospective survey of endoscopic retrograde cholangio-pancreatograph practice. Gut 2007; 56: 821-829
3 Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc 2005; 61: 112-125
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 Freeman ML, DiSario JA, Nelson DB et al. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc 2001; 54: 425-434
6 Testoni PA, Testoni S, Giussani A. Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis. Dig Liver Dis 2011; 43: 596-603
7 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
8 Dumonceau JM, 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
9 Masci E, Mariani A, Curioni S et al. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 2003; 35: 830-834
10 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
11 Williams EJ, Taylor S, Fairclough P et al. Risk factors for complication following ERCP; results of a large-scale, prospective multicenter study. Endoscopy 2007; 39: 793-801
12 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
13 Wang P, Li ZS, Liu F et al. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 2009; 104: 31-40
14 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
15 Tang SJ, Haber GB, Kortan P et al. Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial. Endoscopy 2005; 37: 58-65
16 Zhou PH, Yao LQ, Xu MD et al. Application of needle-knife in difficult biliary cannulation for endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int 2006; 5: 590-594
17 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
18 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
19 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
20 Manes G, Di Giorgio P, Repici A et al. An analysis of the factors associated with the development of complications in patients undergoing precut sphincterotomy: a prospective, controlled, randomized, multicenter study. Am J Gastroenterol 2009; 104: 2412-2417
21 Swan MP, 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: 430-436
22 Testoni PA, 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
23 Cennamo V, Fuccio L, Zagari RM et al. Can early precut implementation reduce endoscopic retrograde cholangio-pancreatography related complication risk? Meta-analysis of randomized controlled trials. Endoscopy 2010; 42: 381-388
24 Gong B, Hao L, Bie L et al. Does precut technique improve selective bile duct cannulation or increase post-ERCP pancreatitis rate? A meta-analysis of randomized controlled trials. Surg Endosc 2010; 24: 2670-2680
25 Choudhary A, Winn J, Siddique S et al. Effect of precut sphincterotomy on post-endoscopic retrograde cholangio-pancreatography pancreatitis: a systematic review and meta-analysis. World J Gastroenterol 2014; 20: 4093-4101
26 Navaneethan U, Konjeti R, Venkatesh PG K et al. Early precut sphincterotomy and the risk of endoscopic retrograde cholangio-pancreatography related complications: an updated meta-analysis. World J Gastrointest Endosc 2014; 6: 200-208
27 Sundaralingam P, Masson P, Bourke MJ. Early precut sphincterotomy does not increase risk during endoscopic retrograde cholangiopancreatography in patients with difficult biliary access: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol 2015; 13: 1722-1729
28 Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
29 Geenen JE, Hogan WJ, Dodds WJ et al. The efficacy of endoscopic sphincterotomy after cholecystectomy in patients with sphincter of Oddi dysfunction. N Engl J Med 1989; 320: 82-87
30 Bailey AA, Bourke MJ, Kaffes AJ et al. Needle-knife sphincterotomy: factors predicting its use and the relationship with post-ERCP pancreatitis (with video). Gastrointest Endosc 2010; 71: 266-271
31 Vandervoort J, Soetikno RM, Tham TC et al. Risk factors for complications after performance of ERCP. Gastrointest Endosc 2002; 56: 652-656
32 Mariani A, Giussani A, Di Leo M et al. Guidewire biliary cannulation does not reduce post-ERCP pancreatitis compared with the contrast injection technique in low-risk and high-risk patients. Gastrointest Endosc 2012; 75: 339-346
33 Kaffes AJ, Sriram PV, Rao GV 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
34 Abu-Hamda EM, Baron TH, Simmons DT et al. A retrospective comparison of outcomes using three different precut needle knife techniques for biliary cannulation. J Clin Gastroenterol 2005; 39: 717-721
35 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. Dig Dis Sci 2012; 57: 3286-3292
36 Lopes L, Dinis-Ribeiro M, Rolanda C. Early precut fistulotomy for biliary access: time to change the paradigm of “the later, the better”?. Gastrointest Endosc 2014; 80: 634-641
37 Akaraviputh T, Lohsiriwat V, Swangsri J et al. The learning curve for safety and success of precut sphincterotomy for therapeutic ERCP: a single endoscopist’s experience. Endoscopy 2008; 40: 513-516
38 Fukatsu H, Kawamoto H, Harada R et al. Quantitative assessment of technical proficiency in performing needle-knife precut papillotomy. Surg Endosc 2009; 23: 2066-2072
39 Harewood GC, Baron TH. An assessment of the learning curve for precut biliary sphincterotomy. Am J Gastroenterol 2002; 97: 1708-1712
40 Elmunzer BJ, Scheiman JM, Lehman GA et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012; 366: 1414-1422
41 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
42 Cha SW, Leung WD, Lehman GA et al. Does leaving a main pancreatic duct stent in place reduce the incidence of precut biliary sphincterotomy-associated pancreatitis? A randomized, prospective study. Gastrointest Endosc 2013; 77: 209-216