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Pre-cut sphincterotomy: does the timing matter?

2009; Elsevier BV; Volume: 69; Issue: 3 Linguagem: Inglês

10.1016/j.gie.2008.11.030

1097-6779

Sri Prakash Misra,

Cholangiocarcinoma and Gallbladder Cancer Studies

To clarify the issue of timing of pre-cut sphincterotomy (PS), a multicenter randomized trial of the timing of PS is warranted.ERCP and endoscopic sphincterotomy are commonly performed procedures for a wide variety of biliary and pancreatic disorders. However, they are considered the most complex procedures in GI endoscopy and have the dubious distinction of being procedures associated with the maximum complications.1Mallery J.S. Baron T.H. Dominitz J.A. et al.Complications of ERCP.Gastrointest Endosc. 2003; 57: 633-638Abstract Full Text Full Text PDF PubMed Scopus (172) Google Scholar, 2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 3Cotton P.B. Lehman G. Vennes J. et al.Endoscopic sphincterotomy complications and their management: an attempt at a consensus.Gastrointest Endosc. 1991; 37: 383-393Abstract Full Text PDF PubMed Scopus (2505) Google Scholar, 4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar, 5Loperfido S. Angelini G. Benedetti G. et al.Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Gastrointest Endosc. 1998; 48: 1-10Abstract Full Text Full Text PDF PubMed Scopus (1066) Google Scholar In a large multicenter prospective study from the United States, overall complications were noted in 9.8% of patients undergoing biliary sphincterotomy. Pancreatitis (5.4%) was the most common complication.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar To clarify the issue of timing of pre-cut sphincterotomy (PS), a multicenter randomized trial of the timing of PS is warranted. Deep biliary cannulation, the hallmark for a successful therapeutic biliary ERCP, has an overall success rate between 90% and 95%. However, in about 5% to 10% of procedures, even after applying several maneuvers, eg, bowing of the sphincterotome and the use of guidewires, access to the bile duct remains elusive, even in experienced hands.5Loperfido S. Angelini G. Benedetti G. et al.Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Gastrointest Endosc. 1998; 48: 1-10Abstract Full Text Full Text PDF PubMed Scopus (1066) Google Scholar, 6Cortas 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 sphincterotome.Gastrointest Endosc. 1999; 50: 775-779Abstract Full Text Full Text PDF PubMed Scopus (99) Google Scholar, 7Schwacha H. Allgaier H.P. Deibert P. et al.A sphincterotome-based technique for selective transpapillary common bile duct cannulation.Gastrointest Endosc. 2000; 52: 387-391Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar, 8Larkin C.J. Huibregtse K. Precut sphincterotomy: indications, pitfalls, and complications.Curr Gastroenterol Rep. 2001; 3: 147-153Crossref PubMed Scopus (34) Google Scholar In these patients, the special incisional technique of pre-cut sphincterotomy (PS), with or without the placement of a prophylactic pancreatic stent, has been used to gain biliary access. During the last decade or so, multivariate analyses have identified a number of risk factors for post-ERCP pancreatitis (PEP) that can be divided into patient related, procedure related, and endoscopist related.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar, 9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar There are high-risk patient factors, including sphincter of Oddi dysfunction, female sex, young patient, prior history of PEP, history of recurrent acute pancreatitis, and the absence of chronic pancreatitis.4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar, 10Copper S.T. Silvka A. Incidence, risk factor, and prevention of post-ERCP pancreatitis.Gastroenterol Clin N Am. 2007; 36: 250-276Google Scholar More important are the procedure-related risk factors for post-ERCP complications. In one study, difficulty in cannulating the bile duct, the use of a combined percutaneous-endoscopic procedure, and the use of PS were noted to lead to complications on multivariate analysis.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar Injection of a contrast agent in the pancreatic duct is a well-known risk factor for PEP. The risk has been noted to increase incrementally with the number of pancreatic-duct injections. In 1 multicenter prospective study, 16.8% of patients with 2 or more pancreatic-duct injections developed pancreatitis.11Cheng C.L. Sherman S. Watkins J.L. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 2006; 101: 139-147Crossref PubMed Scopus (514) Google Scholar The extent to which the pancreatic duct is opacified has also been suggested to be an important risk factor. In a retrospective study of a large number of patients undergoing ERCP, pancreatitis was observed in only 0.8% of patients in whom the pancreatic-duct injection was not attempted or the ERCP failed, 3.6% in patients in whom contrast was injected in the pancreatic duct up to the pancreatic head, in 4.5% when the body was opacified, and as high as 8.6% when the complete pancreatic duct was opacified.12Cheon Y.R. Cho K.B. Watkins J.L. et al.Frequency and severity of post-ERCP pancreatitis correlated with the extent of pancreatic ductal opacification.Gastrointest Endosc. 2007; 65: 385-393Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar In yet another study, it was observed that the odds ratio for PEP was 3.5 when there was complete filling of the pancreatic duct with contrast agent. The risk increased incrementally with each attempt at cannulation of the papilla. The odds ratio was 1.4 per attempt and was greater than 10% after 4 or more attempts.13Bailey A.A. Bourke M.J. Williams S.J. et al.A prospective randomized trial of cannulation techniques in ERCP: effects on technical success and post-ERCP pancreatitis.Endoscopy. 2008; 40: 296-301Crossref PubMed Scopus (194) Google Scholar Difficulty in cannulation is also a risk factor for PEP.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar, 9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar Again, the risk increases incrementally with the number of failed cannulation attempts. In 1 study, after biliary sphincterotomy, pancreatitis occurred in 3% of patients when cannulation was considered "easy" (1-5 attempts), in 7% after "moderate difficult" cannulation (6-15 attempts), and in 13% of cases when cannulation was considered "difficult" (>15 attempts).2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar Vandervoort et al,9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar in a prospective study, noted that pancreatitis occurred in 3.3% of patients who required fewer than 5 attempts for biliary cannulation, 9% when 6 to 20 cannulation attempts were needed, and 14.9% when the cannulation attempts were more than 20. Although PS is a very useful tool in achieving biliary-ductal access when cannulation of the bile duct is not possible by the conventional method, it is not a simple procedure. It has been observed to be an independent risk factor for post-ERCP complications in several prospective studies,2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar, 10Copper S.T. Silvka A. Incidence, risk factor, and prevention of post-ERCP pancreatitis.Gastroenterol Clin N Am. 2007; 36: 250-276Google Scholar and it is recommended that PS be performed only by experts.14Cotton P.B. Precut sphincterotomy: a risky technique for experts only.Gastrointest Endosc. 1997; 46: 282-284Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar Commonly reported complication rates for PS vary between 8% and 10%.15Foutch P.G. A prospective assessment of results of needle-knife papillotomy and standard endoscopic sphincterotomy.Gastrointest Endosc. 1995; 41: 25-32Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar, 16Rabenstein T. Ruppert T. Schneider H.T. et al.Benefits and risks of needle-knife papillotomy.Gastrointest Endosc. 1997; 46: 207-211Abstract Full Text Full Text PDF PubMed Scopus (96) Google Scholar, 17Rollhauser C. Johnson M. Al-Kawas F.H. Needle-knife papillotomy: a helpful and safe adjunct to endoscopic retrograde cholangio-pancreatography in a selected population.Endoscopy. 1998; 30: 691-696Crossref PubMed Scopus (53) Google Scholar, 18Mavrogiannis C. Liatsos C. Romanos A. et al.Needle-knife fistulotomy versus needle-knife precut papillotomy for the treatment of common bile duct stones.Gastrointest Endosc. 1999; 50: 334-339Abstract Full Text Full Text PDF PubMed Scopus (140) Google Scholar Much higher complication rates, up to 22%, have also been reported.19Bruins Slot W. 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: 334-339Crossref PubMed Scopus (127) Google Scholar, 20Kasmin F.E. Cohen D. Batra S. et al.Needle-knife sphincterotomy in a tertiary referral center: efficacy and complications.Gastrointest Endosc. 1996; 44: 48-53Abstract Full Text Full Text PDF PubMed Scopus (120) Google Scholar, 21Bolzan H.E. Spatola J. Gonzalez J. et al.Precut Vater's papilla. Prospective evaluation of frequency of use, effectiveness, complications and mortality.Acta Gastroenterol Latinoam. 2001; 31: 323-327PubMed Google Scholar, 22de la Morena E.J. Dominguez M. Lumbreras M. et al.Self-training in needle-knife sphincterotomy.Gastroenterol Hepatol. 2000; 23: 109-115PubMed Google Scholar In 1 study, pancreatitis occurred in 15.3% of patients who required PS compared with only 4.5% of patients undergoing ERCP but not requiring PS. More startling was that, when PS was performed on patients suspected to have sphincter of Oddi dysfunction, the PEP rate was an astounding 35.3% compared with 11.3% when PS was used for other indications. Severe pancreatitis was observed in 25% of patients with sphincter of Oddi dysfunction versus only 2% when PS was used for other indications.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar Also, in a meta-analysis, PS was associated with an increased risk of PEP (odds ratio 2.7).23Masci E. Toti G. Mariani A. et al.Complication of diagnostic and therapeutic ERCP: a prospective multicenter study.Am J Gastroenterol. 2001; 96: 417-423Crossref PubMed Google Scholar Why does PS lead to higher complication rates? PS, when using a needle-knife, is a freehand technique and may have a higher chance of injuring the pancreatic sphincter, which leads to inflammation, edema, and ductal obstruction, all of which predispose to the occurrence of PEP. Because the incision is not well controlled (because it is not wire guided),24Burdick J.S. London A. Thompson D. Intramural incision technique.Gastrointest Endosc. 2002; 55: 425-427Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar, 25Misra S.P. Dwivedi M. Intramural incision technique: a useful and safe procedure for obtaining ductal access during ERCP.Gastrointest Endosc. 2008; 67: 629-633Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar perforations and bleeding may also be observed more frequently with the procedure. However, many investigators believe that this technique is unduly maligned, because, by the time PS is contemplated, the patient is already at a higher risk of complication from the trauma, edema, and inflammation that occur to the papillary area and inadvertent pancreatic-duct cannulations after repeated unsuccessful attempts to achieve biliary-ductal cannulation.9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar, 26Vandervoort J. Carr-Locke D.L. Needle knife access papillotomy: an unfairly maligned technique.Endoscopy. 1996; 28: 365-366Crossref PubMed Scopus (60) Google Scholar, 27de Weerth A. Seltz U. Zhong Y. et al.Primary precutting versus conventional over-the-wire sphincterotomy for bile duct access: a prospective randomized study.Endoscopy. 2006; 38: 1235-1240Crossref PubMed Scopus (68) Google Scholar, 28Kaffes A.J. Sriram P.V. Rao G.V. et al.Early institution of pre-cutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique.Gastrointest Endosc. 2005; 62: 669-674Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar It has been assessed that, by the time PS is contemplated, the risk of PEP has already reached 14%. When PS is performed, the risk increases to 29%.26Vandervoort J. Carr-Locke D.L. Needle knife access papillotomy: an unfairly maligned technique.Endoscopy. 1996; 28: 365-366Crossref PubMed Scopus (60) Google Scholar This finding has led investigators to recommend early use of PS.26Vandervoort J. Carr-Locke D.L. Needle knife access papillotomy: an unfairly maligned technique.Endoscopy. 1996; 28: 365-366Crossref PubMed Scopus (60) Google Scholar, 27de Weerth A. Seltz U. Zhong Y. et al.Primary precutting versus conventional over-the-wire sphincterotomy for bile duct access: a prospective randomized study.Endoscopy. 2006; 38: 1235-1240Crossref PubMed Scopus (68) Google Scholar, 28Kaffes A.J. Sriram P.V. Rao G.V. et al.Early institution of pre-cutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique.Gastrointest Endosc. 2005; 62: 669-674Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar In this issue of Gastrointestinal Endoscopy, Cennamo et al29Cennamo 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: 473-479Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar report results of their study that evaluated the success rate and complications of the timing of PS in a prospective randomized trial. The investigators performed therapeutic ERCP procedures on 1078 patients. Cannulation of the bile duct was attempted by using a sphincterotome and guidewire. Contrast agent was not used. A total of 146 patients in whom deep biliary cannulation could not be achieved within 5 minutes or the pancreatic duct was inadvertently cannulated at least thrice formed the study group. These patients were randomly allocated in a 1:3 ratio to a group in which early PS was performed (immediately after randomization, with no further probing of the papilla, group A [n = 36]) or to a group in which persistent cannulation attempts were made for a further period of 20 minutes with no limit on the number of pancreatic-duct cannulations (group B [n = 110]). Patients in group B were further subdivided into group B1, in which deep cannulation of the bile duct could be achieved within a further period of 20 minutes (n = 78), and group B2, in which, despite all attempts within 20 minutes, cannulation of the common bile duct could not be achieved (n = 32). Needle-knife PS was also performed in these patients (group B2). The investigators did not resort to prophylactic pancreatic-duct stent placement. After achieving access to the bile duct, conventional biliary sphincterotomy was performed. If the bile duct could not be cannulated in the first attempt after PS (either in group A or group B2), then another attempt was made after 48 hours, with either a standard approach for biliary cannulation (duration not mentioned) or another PS. The patients had a mix of malignant biliary obstruction (27%) and choledocholithiasis (73%). The etiology of malignant biliary obstruction was not mentioned. The complications were defined and classified according to the accepted protocol.3Cotton P.B. Lehman G. Vennes J. et al.Endoscopic sphincterotomy complications and their management: an attempt at a consensus.Gastrointest Endosc. 1991; 37: 383-393Abstract Full Text PDF PubMed Scopus (2505) Google Scholar However, it is important to note that mild pancreatitis was not considered a complication, which would definitely have led to underreporting of PEP. The investigators achieved deep cannulation of the bile duct in 92% of patients in group A versus 95% in group B. In group B, biliary cannulation was achieved by the conventional method (by using a sphincterotome and guidewire) in 78 patients (71%) (group B1). The remaining 32 (29%) required PS even after 20 minutes of further attempts at biliary cannulation (group B2). The first attempt at cannulating the bile duct failed in 9 patients (3 in group A and 6 in group B1) after PS. All the failures were because of edema. A second attempt at cannulation was successful in all of these patients. Two patients (1 each in groups A and B1) required a second PS. Complications occurred in 8% of patients in group A (1 retroduodenal perforation, 1 bleeding and 1 moderate pancreatitis) versus 6% for patients in group B (all in subgroup B1: 7 moderate pancreatitis and 1 bleeding). All the complications could be managed conservatively. No patient developed severe PEP, and there was no casualty. The investigators conclude that the timing of PS does not influence success and complication of the ERCP procedure. Earlier, in an elegant study, de Weerth et al27de Weerth A. Seltz U. Zhong Y. et al.Primary precutting versus conventional over-the-wire sphincterotomy for bile duct access: a prospective randomized study.Endoscopy. 2006; 38: 1235-1240Crossref PubMed Scopus (68) Google Scholar studied 291 patients undergoing therapeutic ERCP. They were randomized to receive either guidewire cannulation, followed by sphincterotomy or a modified Erlangen-type PS. The results demonstrated that PS was effective and safe, and the use of pre-cutting as the primary cannulation technique to reduce complications was recommended.27de Weerth A. Seltz U. Zhong Y. et al.Primary precutting versus conventional over-the-wire sphincterotomy for bile duct access: a prospective randomized study.Endoscopy. 2006; 38: 1235-1240Crossref PubMed Scopus (68) Google Scholar However, this study was performed at a center where the endoscopists were well versed with the use of the Erlangen type of PS. Whether or not the results could be replicated with the freehand technique by using a needle-knife remains to be answered. In another study, Kaffes et al28Kaffes A.J. Sriram P.V. Rao G.V. et al.Early institution of pre-cutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique.Gastrointest Endosc. 2005; 62: 669-674Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar performed needle-knife PS (below upward or above downward) if they failed to cannulate the common bile duct within 10 minutes or if there were >5 pancreatic-duct injections of contrast agent. They also used guidewire cannulation technique, if needed. The overall success for cannulation of the bile duct was 96.5%, with no difference in the complication rate by either technique of PS. The investigators concluded that early use of needle-knife PS was safe and effective.28Kaffes A.J. Sriram P.V. Rao G.V. et al.Early institution of pre-cutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique.Gastrointest Endosc. 2005; 62: 669-674Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar However, Tang et al30Tang S.J. Haber G.B. Kortan P. et al.Precut papillotomy versus persistence in difficult biliary cannulation.Endoscopy. 2005; 37: 58-65Crossref PubMed Scopus (106) Google Scholar noted no difference in the success and complication rates whether PS was performed early (after failure to cannulate the bile duct within 12 minutes) or after several attempts at cannulation for a further period of 15 minutes. The investigators randomized patients in whom they could not achieve bile-duct cannulation to an immediate pre-cut arm (n = 32) or to a persistence arm wherein they persisted with attempts to cannulate the bile duct with a nonwire-guided, single-lumen sphincterotome. Primary success was defined as cannulation of the bile duct within 15 minutes of randomization. The primary success and complication rates were found to be similar in both arms of the study.30Tang S.J. Haber G.B. Kortan P. et al.Precut papillotomy versus persistence in difficult biliary cannulation.Endoscopy. 2005; 37: 58-65Crossref PubMed Scopus (106) Google Scholar All the studies mentioned above have used different techniques (contrast injection and guidewire-aided cannulation), accessories (single-lumen or triple-lumen sphincterotomes, modified Erlangen-type pre-cut sphincterotome, and needle-knife), varying time limits before pre-cutting and the number of unwanted pancreatic-duct cannulations. More importantly, the patient characteristics also were quite different and so the studies are, strictly speaking, not comparable. However, despite this, the results of the study by Cennamo et al29Cennamo 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: 473-479Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar appear to be similar to those reported by Tang et al.30Tang S.J. Haber G.B. Kortan P. et al.Precut papillotomy versus persistence in difficult biliary cannulation.Endoscopy. 2005; 37: 58-65Crossref PubMed Scopus (106) Google Scholar One difference was that Cennamo et al29Cennamo 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: 473-479Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar defined a new group: patients in whom, after failure to achieve deep cannulation of the bile duct for a further period of 20 minutes, PS was performed (group B2). It is surprising to note that, in this group, no complications were observed although PS was performed on a presumably traumatized papilla that was probed for a further period of 20 minutes. Whereas, in group B1, in which, after persisting for a mean of 7.6 minutes (range 0.4-18 minutes), complications were observed in 6% of patients. The apparent disparity appears to be because of the small number of patients in the 2 subgroups and, as also stated by the investigators, the number of patients enrolled in the study is small and the study may be underpowered to detect minor differences between the groups. It is known that the experience and skills of the endoscopist influence the occurrence of post-ERCP complications.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar, 9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar, 10Copper S.T. Silvka A. Incidence, risk factor, and prevention of post-ERCP pancreatitis.Gastroenterol Clin N Am. 2007; 36: 250-276Google Scholar Studies have demonstrated that the complication rates are lower when the procedure is performed by endoscopists with a higher volume load and experience.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar However, an increased risk with endoscopists with a lower volume load has been difficult to ascertain.10Copper S.T. Silvka A. Incidence, risk factor, and prevention of post-ERCP pancreatitis.Gastroenterol Clin N Am. 2007; 36: 250-276Google Scholar In another multicenter study, the risk of PEP was significantly higher when fellows performed the ERCP.11Cheng C.L. Sherman S. Watkins J.L. et al.Risk factors for post-ERCP pancreatitis: a prospective multicenter study.Am J Gastroenterol. 2006; 101: 139-147Crossref PubMed Scopus (514) Google Scholar In the study by Cennamo et al,29Cennamo 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: 473-479Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar the 2 endoscopists performing the procedures were well experienced, having performed more than 2500 ERCP procedures. Their workload was also high, with each performing >250 procedures a year, and about 7% to 10% of these procedures required PS. However, even with their relatively large experience, although the success rate for all patients was 100%, the complication rates were similar to that observed in most studies, even though the investigators did not include mild PEP as a complication and did not have any patient suspected of having sphincter of Oddi dysfunction. Also, in an earlier study, the overall success rate for bile-duct cannulation was noted to be significantly higher when the procedure was performed by endoscopists with high-volume loads, who perform more than 2 ERCPs a week, versus endoscopists with low-volume loads. However, the chances of PEP were similar.4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar Similarly, endoscopists with high-volume loads need a significantly lower number of attempts for achieving successful cannulation and have fewer inadvertent pancreatic-duct cannulations. However, again, PEP rates were similar, being 5.5% for endoscopists with high-volume loads and 5.3% for endoscopists with lower-volume loads.2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar So, what should the policy be: to perform PS early after failure to achieve deep cannulation of bile duct (for 5-12 minutes) or to persist with cannulation attempts for a further defined period of time, resorting to PS only if after this defined period of time, deep cannulation of the bile duct is not achieved? Cennamo et al29Cennamo 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: 473-479Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar do not give us any recommendation. By following the latter policy, they could successfully achieve sphincterotomy in 70 of 110 patients (71%). Even in those in whom deep cannulation of the bile duct could not be achieved after further 20 minutes (group B2), PS followed by conventional sphincterotomy was successful in all patients without any complication. However, there was no difference in the success or complication rates if group A and group B (B1 + B2) were compared. To clarify the issue of timing of PS, a multicenter randomized trial of the timing of PS is warranted. The study should include a large number of patients so that it is powered to detect small differences between the groups. More importantly, it should include a more heterogeneous group of patients, with a mix of those with low and high risks of expected complications. However, until the result of such a study is published, considering that difficult cannulation2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 4Freeman M.L. Disario J.A. Nelson D.B. et al.Risk factors for post-ERCP pancreatitis.Gastrointest Endosc. 2001; 54: 425-434Abstract Full Text Full Text PDF PubMed Scopus (1039) Google Scholar, 9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar as well as PS2Freeman M.L. Nelson D.B. Sherman S. et al.Complications of biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918Crossref PubMed Scopus (2254) Google Scholar, 9Vandervoort J. Soetikno R.M. Tham T.C. et al.Risk factors for complications after performance of ERCP.Gastrointest Endosc. 2002; 56: 652-656Abstract Full Text Full Text PDF PubMed Scopus (498) Google Scholar, 10Copper S.T. Silvka A. Incidence, risk factor, and prevention of post-ERCP pancreatitis.Gastroenterol Clin N Am. 2007; 36: 250-276Google Scholar are known independent factors for post-ERCP complications as well as the findings of the studies showing benefit of early PS,26Vandervoort J. Carr-Locke D.L. Needle knife access papillotomy: an unfairly maligned technique.Endoscopy. 1996; 28: 365-366Crossref PubMed Scopus (60) Google Scholar, 27de Weerth A. Seltz U. Zhong Y. et al.Primary precutting versus conventional over-the-wire sphincterotomy for bile duct access: a prospective randomized study.Endoscopy. 2006; 38: 1235-1240Crossref PubMed Scopus (68) Google Scholar, 28Kaffes A.J. Sriram P.V. Rao G.V. et al.Early institution of pre-cutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique.Gastrointest Endosc. 2005; 62: 669-674Abstract Full Text Full Text PDF PubMed Scopus (100) Google Scholar it would be prudent to perform PS early in the course of an ERCP procedure. Even if all things were equal between early and delayed PS, early PS would at least save on time, medications, anesthesia, and, hopefully, some money too. The author disclosed no financial relationships relevant to this publication.