A prospective randomized trial of cannulation technique in ERCP: effects on technical success and post-ERCP pancreatitis

Background and study aims: Inadvertent injection of contrast agent into the pancreatic duct is believed to be an important contributor to pancreatitis occurring after endoscopic retrograde cholangiopancreatography (post-ERCP pancreatitis, PEP). Our aim was to examine whether primary deep biliary cannulation with a guide wire is associated with a lower rate of PEP than conventional contrast-assisted cannulation.

Patients and methods: From August 2003 to April 2006 all patients with an intact papilla who were referred for ERCP were eligible. Patients with pancreatic or ampullary cancer were excluded. Patients were randomized to undergo sphincterotome biliary cannulation using either contrast injection or a guide wire. The ERCP fellow attempted initially for 5 minutes. If unsuccessful, the consultant attempted for 5 minutes using the same technique, followed by crossover to the other technique in the same sequence and then needle-knife sphincterotomy where appropriate. Patients were assessed clinically after the procedure, then followed up with telephone interviews after 24 hours and 30 days, and serum amylase and lipase tests after 24 hours.

Results: Out of 1654 patients undergoing ERCP, 413 were included in the study. PEP occurred in 29/413 (7.0 %): 16 in the guide-wire arm, 13 in the contrast arm (P = 0.48). The overall cannulation success rate was 97.3 %. Cannulation was successful without crossover in 323/413 patients (78.2 %): 167/202 (81.4 %) in the guide-wire arm and 156/211 (73.9 %) in the contrast arm (P = 0.03). Multivariate analysis demonstrated female sex (OR = 2.7, P = 0.04), suspected sphincter of Oddi dysfunction (OR = 5.5, P = 0.01), and complete filling of the pancreatic duct with contrast agent (OR = 3.5, P = 0.02) to be independently associated with PEP. The risk of PEP increased incrementally with each attempt at the papilla (OR 1.4 per attempt, P = 0.04) to greater than 10 % after four or more attempts.

Conclusions: The guide-wire technique improves the primary success rate for biliary cannulation during ERCP but does not reduce the incidence of PEP compared to the conventional contrast technique. The incidence of PEP increases incrementally with each attempt at the papilla.

References

• 1 McCune W S, Shorb P E, Moscovitz H. Endoscopic cannulation of the ampulla of Vater: a preliminary report.  Ann Surg. 1968;  167 752-756
• 2 Classen M, Demling L. [Endoscopic sphincterotomy of the papilla of Vater and extraction of stones from the choledochal duct (author’s transl)].  Dtsch Med Wochenschr. 1974;  99 496-497
• 3 Adler D G, Baron T H, Davila R E. et al . ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas.  Gastrointest Endosc. 2005;  62 1
• 4 Freeman M L, Nelson D B, Sherman S. et al . Complications of endoscopic biliary sphincterotomy.  N Engl J Med. 1996;  335 909-918
• 5 Rochester J S, Jaffe D L. Minimizing complications in endoscopic retrograde cholangiopancreatography and sphincterotomy.  Gastrointest Endosc Clin N Am. 2007;  17 105-127, vii
• 6 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 cholangio-pancreatograph practice.  Gut. 2007;  56 821-829
• 7 Varadarajulu S, Kilgore M L, Wilcox C M. et al . Relationship among hospital ERCP volume, length of stay, and technical outcomes.  Gastrointest Endosc. 2006;  64 338-347
• 8 Disario J A. Hospital volume and ERCP outcomes: the writing is on the wall.  Gastrointest Endosc. 2006;  64 348-350
• 9 Speer A G, Cotton P B, Russell R C. et al . Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice.  Lancet. 1987;  2 57-62
• 10 Christoforidis E, Goulimaris I, Kanellos I. et al . Post-ERCP pancreatitis and hyperamylasemia: patient-related and operative risk factors.  Endoscopy. 2002;  34 286-292
• 11 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
• 12 Boender J, Nix G A, de Ridder M A. et al . Endoscopic papillotomy for common bile duct stones: factors influencing the complication rate.  Endoscopy. 1994;  26 209-216
• 13 Sherman S, Ruffolo T A, Hawes R H. et al . Complications of endoscopic sphincterotomy. A prospective series with emphasis on the increased risk associated with sphincter of Oddi dysfunction and nondilated bile ducts.  Gastroenterology. 1991;  101 1068-1075
• 14 Friedland S, Soetikno R M, Vandervoort J. et al . Bedside scoring system to predict the risk of developing pancreatitis following ERCP.  Endoscopy. 2002;  34 483-488
• 15 Mallery J S, Baron T H, Dominitz J A. et al . Complications of ERCP.  Gastrointest Endosc. 2003;  57 633-638
• 16 Freeman M L, Guda N M. ERCP cannulation: a review of reported techniques.  Gastrointest Endosc. 2005;  61 112-125
• 17 Maydeo A, Borkar D. Techniques of selective cannulation and sphincterotomy.  Endoscopy. 2003;  35 S19-S23
• 18 Cortas 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 sphincterotomes.  Gastrointest Endosc. 1999;  50 775-779
• 19 Laasch H U, Tringali A, Wilbraham L. et al . Comparison of standard and steerable catheters for bile duct cannulation in ERCP.  Endoscopy. 2003;  35 669-674
• 20 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
• 21 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
• 22 Freeman M L. Toward improving outcomes of ERCP.  Gastrointest Endosc. 1998;  48 96-102
• 23 Andriulli A, Leandro G, Niro G. et al . Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis.  Gastrointest Endosc. 2000;  51 1-7
• 24 Deviere J, Le Moine O, Van Laethem J L. et al . Interleukin 10 reduces the incidence of pancreatitis after therapeutic endoscopic retrograde cholangiopancreatography.  Gastroenterology. 2001;  120 498-505
• 25 Sudhindran S, Bromwich E, Edwards P R. Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreatography-induced pancreatitis.  Br J Surg. 2001;  88 1178-1182
• 26 Ghori A, Hallisey M, Nwokolo C. et al . The secret (GTN) of successful ERCP cannulation: a prospective randomised controlled study.  J R Coll Surg Edinb. 2002;  47 634-637
• 27 Poon R T, Yeung C, Liu C L. et al . Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomised controlled trial.  Gut. 2003;  52 1768-1773
• 28 Masci E, Cavallini G, Mariani A. et al . Comparison of two dosing regimens of gabexate in the prophylaxis of post-ERCP pancreatitis.  Am J Gastroenterol. 2003;  98 2182-2186
• 29 Arvanitidis D, Anagnostopoulos G K, Giannopoulos D. et al . Can somatostatin prevent post-ERCP pancreatitis? Results of a randomized controlled trial.  J Gastroenterol Hepatol. 2004;  19 278-282
• 30 Rabenstein T, Roggenbuck S, Framke B. et al . Complications of endoscopic sphincterotomy: can heparin prevent acute pancreatitis after ERCP?.  Gastrointest Endosc. 2002;  55 476-483
• 31 Moreto M, Zaballa M, Casado I. et al . Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: a randomized double-blind trial.  Gastrointest Endosc. 2003;  57 1-7
• 32 Kaffes A J, Bourke M J, Ding S. et al . A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis.  Gastrointest Endosc. 2006;  64 351-357
• 33 Dumot J A, Conwell D L, Zuccaro Jr G. et al . A randomized, double blind study of interleukin 10 for the prevention of ERCP-induced pancreatitis.  Am J Gastroenterol. 2001;  96 2098-2102
• 34 Andriulli A, Leandro G, Federici T. et al . Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis.  Gastrointest Endosc. 2007;  65 624-32
• 35 Cheon Y K, Cho K B, Watkins J L. et al . Frequency and severity of post-ERCP pancreatitis correlated with extent of pancreatic ductal opacification.  Gastrointestinal Endoscopy. 2007;  65 385
• 36 Singh P, Das A, Isenberg G. et al . Does prophylactic pancreatic stent placement reduce the risk of post-ERCP acute pancreatitis? A meta-analysis of controlled trials.  Gastrointest Endosc. 2004;  60 544-550
• 37 Freeman M L, Overby C, Qi D. Pancreatic stent insertion: consequences of failure and results of a modified technique to maximize success.  Gastrointest Endosc. 2004;  59 8-14
• 38 Freeman M L, Guda N M. Prevention of post-ERCP pancreatitis: a comprehensive review.  Gastrointest Endosc. 2004;  59 845-864
• 39 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
• 40 Brackbill S, Young S, Schoenfeld P. et al . A survey of physician practices on prophylactic pancreatic stents.  Gastrointest Endosc. 2006;  64 45-52
• 41 Goldberg E, Titus M, Haluszka O. et al . Pancreatic-duct stent placement facilitates difficult common bile duct cannulation.  Gastrointest Endosc. 2005;  62 592-596
• 42 Lella F, Bagnolo F, Colombo E. et al . A simple way of avoiding post-ERCP pancreatitis.  Gastrointest Endosc. 2004;  59 830-834