Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials

 

 Buy Article Permissions and Reprints

Background and study aims: Precut papillotomy is considered a risk factor for endoscopic retrograde cholangiopancreatography (ERCP)-related complications; however whether the complication risk is due to precut itself or to the prior prolonged attempts is still debated; therefore, early precut implementation has been suggested to reduce the complication rate. We conducted a meta-analysis of randomized controlled trials (RCTs) comparing cannulation and complication rates of early precut implementation with persistent attempts by the standard approach.

Methods: RCTs that compared cannulation and complication rates of the early precut implementation and of persistent attempts by the standard approach were included. Summary effect sizes were estimated by odds ratio (OR) with a random-effects model and by Peto OR.

Results: Six RCTs with a total of 966 subjects met the inclusion criteria. Overall cannulation rates were 90 % in both randomization groups (OR 1.20; 95 % confidence interval [CI] 0.54 – 2.69). Post-ERCP pancreatitis developed in 2.5 % of patients randomized to the early precut groups and in 5.3 % of patients from the persistent attempts groups (OR 0.47; 95 %CI 0.24 – 0.91). The overall complication rates, considering pancreatitis, bleeding, cholangitis, and perforation rates, were 5.0 % in the early precut groups and 6.3 % in the persistent attempts groups (OR 0.78; 95 %CI 0.44 – 1.37).

Conclusions: RCTs that investigated the issue of timing of the precut procedure were limited. Current evidence suggests that in experienced hands the early implementation of precut and persistent cannulation attempts have similar overall cannulation rates; early precut implementation reduces post-ERCP pancreatitis risk but not the overall complication rate. Further studies are needed to confirm these findings.

References

• 1 Huibregtse K, Katon R M, Tytgat G N. Precut papillotomy via fine-needle knife papillotome: a safe and effective technique.  Gastrointest Endosc. 1986;  32 403-405
  CrossrefPubMedGoogle Scholar
• 2 Binmoeller K F, Seifert H, Gerke H. et al . Papillary roof incision using the Erlangen-type pre-cut papillotome to achieve selective bile duct cannulation.  Gastrointest Endosc. 1996;  44 689-695
  CrossrefPubMedGoogle Scholar
• 3 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
  CrossrefPubMedGoogle Scholar
• 4 Larkin C J, Huibregtse K. Precut sphincterotomy: indications, pitfalls, and complications.  Curr Gastroenterol Rep. 2001;  3 147-153
  CrossrefPubMedGoogle Scholar
• 5 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
  CrossrefPubMedGoogle Scholar
• 6 Shakoor T, Geenen J E. Pre-cut papillotomy.  Gastrointest Endosc. 1992;  38 623-627
  CrossrefPubMedGoogle Scholar
• 7 Freeman M L, Guda N M. ERCP cannulation: a review of reported techniques.  Gastrointest Endosc. 2005;  61 112-125
  CrossrefPubMedGoogle Scholar
• 8 Sriram P V, Rao G V, Nageshwar R eddy. The precut – when, where and how? A review.  Endoscopy. 2003;  35 S24-S30
  Article in Thieme ConnectPubMedGoogle Scholar
• 9 Tang S J, Haber G B, Kortan P. et al . Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial.  Endoscopy. 2005;  37 58-65
  Article in Thieme ConnectPubMedGoogle Scholar
• 10 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
  CrossrefPubMedGoogle Scholar
• 11 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
  Article in Thieme ConnectPubMedGoogle Scholar
• 12 Moher D, Cook D J, Eastwood S. et al . Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.  Lancet. 1999;  354 1896-1900
  CrossrefPubMedGoogle Scholar
• 13 Greenland S. Meta-analysis. In: Rothman KJ GS, ed Modern Epidemiology. 2nd ed. Philadelphia; Lippincot-Raven 1998: 643-673
  PubMedGoogle Scholar
• 14 Juni P, Altman D G, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials.  BMJ. 2001;  323 42-46
  CrossrefPubMedGoogle Scholar
• 15 Fuccio L, Guido A, Eusebi L H. et al . Effects of probiotics for the prevention and treatment of radiation-induced diarrhea.  J Clin Gastroenterol. 2009;  43 506-513
  CrossrefPubMedGoogle Scholar
• 16 Cennamo V, Fuccio L, Zagari R M. et al . Can a wire-guided cannulation technique increase bile duct cannulation rate and prevent post-ERCP pancreatitis? A meta-analysis of randomized controlled trials.  Am J Gastroenterol. 2009;  104 2343-2350
  CrossrefPubMedGoogle Scholar
• 17 Fuccio L, Zagari R M, Eusebi L H. et al . Meta-analysis: can Helicobacter pylori eradication treatment reduce the risk for gastric cancer?.  Ann Intern Med. 2009;  151 121-128
  CrossrefPubMedGoogle Scholar
• 18 Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease.  J Natl Cancer Inst. 1959;  22 719-748
  PubMedGoogle Scholar
• 19 DerSimonian R, Laird N. Meta-analysis in clinical trials.  Control Clin Trials. 1986;  7 177-188
  CrossrefPubMedGoogle Scholar
• 20 Begg C B, Mazumdar M. Operating characteristics of a rank correlation test for publication bias.  Biometrics. 1994;  50 1088-1101
  CrossrefPubMedGoogle Scholar
• 21 Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test.  BMJ. 1997;  315 629-634
  CrossrefPubMedGoogle Scholar
• 22 Galbraith R F. A note on graphical presentation of estimated odds ratios from several clinical trials.  Stat Med. 1988;  7 889-894
  CrossrefPubMedGoogle Scholar
• 23 Hedges L V, Olkin I. Statistical methods for meta-analysis. San Diego; Academic Press 1985
  PubMedGoogle Scholar
• 24 Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.0.0 [updated February 2008], chapter 10. The Cochrane Collaboration 2008 http://Available from www.cochrane-handbook.org
  PubMedGoogle Scholar
• 25 Parlak E, Cicek B, Disibeyaz S. et al . Early decision for precut sphincterotomy: is it a risky preference?.  Dig Dis Sci. 2007;  52 845-851
  CrossrefPubMedGoogle Scholar
• 26 Kaffes 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;  62 669-674
  CrossrefPubMedGoogle Scholar
• 27 Joo K, Jung S, Shin H. et al . Early use of needle-knife fistulotomy in patients ith expected difficult biliary cannulation. Abstract presented at UEGW 2009 Nov 21 – 25; London, UK.  GASTRO. 2009;  in press
  Google Scholar
• 28 Zhou P H, Yao L Q, Xu M D. et al . Application of needle-knife in difficult biliary cannulation for endoscopic retrograde cholangiopancreatography.  Hepatobiliary Pancreat Dis Int. 2006;  5 590-594
  PubMedGoogle Scholar
• 29 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
  PubMedGoogle Scholar
• 30 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
  CrossrefPubMedGoogle Scholar
• 31 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
  CrossrefPubMedGoogle Scholar
• 32 Herbert R D, Bo K. Analysis of quality of interventions in systematic reviews.  BMJ. 2005;  331 507-509
  CrossrefPubMedGoogle Scholar
• 33 Schulz K F, Chalmers I, Hayes R J, Altman D G. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.  JAMA. 1995;  273 408-412
  CrossrefPubMedGoogle Scholar
• 34 Bruins S lot, 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
  Article in Thieme ConnectPubMedGoogle Scholar
• 35 Gottlieb K, Sherman S. ERCP and biliary endoscopic sphincterotomy-induced pancreatitis.  Gastrointest Endosc Clin N Am. 1998;  8 87-114
  PubMedGoogle Scholar
• 36 Chen Y K, Foliente R L, Santoro M J. et al . Endoscopic sphincterotomy-induced pancreatitis: increased risk associated with nondilated bile ducts and sphincter of Oddi dysfunction.  Am J Gastroenterol. 1994;  89 327-333
  PubMedGoogle Scholar
• 37 Sherman S, Lehman G A. ERCP- and endoscopic sphincterotomy-induced pancreatitis.  Pancreas. 1991;  6 350-367
  CrossrefPubMedGoogle Scholar
• 38 Kasmin F E, Cohen D, Batra S. et al . Needle-knife sphincterotomy in a tertiary referral center: efficacy and complications.  Gastrointest Endosc. 1996;  44 48-53
  CrossrefPubMedGoogle Scholar
• 39 Vandervoort J, Soetikno R M, Tham T C. et al . Risk factors for complications after performance of ERCP.  Gastrointest Endosc. 2002;  56 652-656
  CrossrefPubMedGoogle Scholar
• 40 Freeman M L, Guda N M. Prevention of post-ERCP pancreatitis: a comprehensive review.  Gastrointest Endosc. 2004;  59 845-864
  CrossrefPubMedGoogle Scholar
• 41 Freeman M L, Nelson D B, Sherman S. et al . Complications of endoscopic biliary sphincterotomy.  N Engl J Med. 1996;  335 909-918
  CrossrefPubMedGoogle Scholar
• 42 Wang P, Li Z S, Liu F. et al . Risk factors for ERCP-related complications: a prospective multicenter study.  Am J Gastroenterol. 2009;  104 31-40
  CrossrefPubMedGoogle Scholar
• 43 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
  CrossrefPubMedGoogle Scholar
• 44 Masci E, Mariani A, Curioni S, Testoni P A. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis.  Endoscopy. 2003;  35 830-834
  Article in Thieme ConnectPubMedGoogle Scholar
• 45 Cotton P B, Garrow D A, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11 497 procedures over 12 years.  Gastrointest Endosc. 2009;  70 80-88
  CrossrefPubMedGoogle Scholar
• 46 Goff J S. Long-term experience with the transpancreatic sphincter pre-cut approach to biliary sphincterotomy.  Gastrointest Endosc. 1999;  50 642-645
  CrossrefPubMedGoogle Scholar
• 47 Baron T H. Complications of endoscopic biliary sphincterotomy: the first cut is the deepest.  Clin Gastroenterol Hepatol. 2004;  2 968-970
  CrossrefPubMedGoogle Scholar
• 48 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
  CrossrefPubMedGoogle Scholar
• 49 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
  CrossrefPubMedGoogle Scholar
• 50 Ioannidis J P, Patsopoulos N A, Rothstein H R. Reasons or excuses for avoiding meta-analysis in forest plots.  BMJ. 2008;  336 1413-1415
  CrossrefPubMedGoogle Scholar
• 51 Mavrogiannis 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;  50 334-339
  CrossrefPubMedGoogle Scholar
• 52 Brackbill S, Young S, Schoenfeld P, Elta G. A survey of physician practices on prophylactic pancreatic stents.  Gastrointest Endosc. 2006;  64 45-52
  CrossrefPubMedGoogle Scholar
• 53 Smithline A, Silverman W, Rogers D. et al . Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients.  Gastrointest Endosc. 1993;  39 652-657
  CrossrefPubMedGoogle Scholar
• 54 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
  CrossrefPubMedGoogle Scholar
• 55 Jacob L, Geenen J E, Catalano M F, Geenen D J. Prevention of pancreatitis in patients with idiopathic recurrent pancreatitis: a prospective nonblinded randomized study using endoscopic stents.  Endoscopy. 2001;  33 559-562
  Article in Thieme ConnectPubMedGoogle Scholar
• 56 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
  Article in Thieme ConnectPubMedGoogle Scholar

F. BazzoliMD 

Dipartimento di Medicina Interna e Gastroenterologia
Università di Bologna
Policlinico S. Orsola

Via Massarenti, 9
40138 Bologna
Italy

Fax: +39-051-6363338

Email: franco.bazzoli@unibo.it