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Endoscopy 2015; 47(10): 884-890
DOI: 10.1055/s-0034-1392418
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Incidence and predictors of post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction undergoing biliary or dual sphincterotomy: results from the EPISOD prospective multicenter randomized sham-controlled study

Mohammad Yaghoobi
1   Division of Gastroenterology, McMaster University, Hamilton Ontario, Canada
2   Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA
,
Qi Pauls
2   Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA
,
Valerie Durkalski
2   Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA
,
Joseph Romagnuolo
2   Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA
,
Evan L. Fogel
3   Division of Gastroenterology/Hepatology, Indiana University Medical Center, Indianapolis, Indiana, USA
,
Paul R. Tarnasky
4   Gastroenterology, Methodist Dallas Medical Center, Dallas, Texas, USA
,
Giuseppe Aliperti
5   Midwest Therapeutic Endoscopy Consultants, St Louis, Missouri, USA
,
Martin L. Freeman
6   University of Minnesota Medical School, Minneapolis, Minnesota, USA
,
Richard A. Kozarek
7   Gastroenterology and Hepatology, Virginia Mason Medical Center, Seattle, Washington, USA
,
Priya A. Jamidar
8   Department of Endoscopy, School of Medicine, Yale University, New Haven, Connecticut, USA
,
Charles M. Wilcox
9   Gastroenterology and Hepatology, University of Alabama, Birmingham, Alabama, USA
,
Grace H. Elta
10   Gastroenterology, University of Michigan, Ann Arbor, Michigan, USA
,
Robert H. Hawes
11   Division of Gastroenterology and Hepatology, Florida Hospital, Orlando, Florida, USA
,
April Wood-Williams
1   Division of Gastroenterology, McMaster University, Hamilton Ontario, Canada
,
Peter B. Cotton
2   Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA
› Author Affiliations
Further Information

Publication History

submitted 05 January 2015

accepted after revision 16 March 2015

Publication Date:
10 July 2015 (online)

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Video Comment on Mohammad Yaghoobi et al.Endoscopy 2015; 47(10): v16-v16
DOI: 10.1055/s-0034-1393121

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Commentaire du travail de Yaghoobi M et al., pp. 884Endoscopy 2015; 47(10): 965-965
DOI: 10.1055/s-0035-1563752

Background and study aim: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population.

Patients and methods: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure.

Results: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 – 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % – 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % – 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02).

Conclusion: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.

Clinicaltrials.gov registration: NCT00688662

 

  • References

  • 1 Behar J, Corazziari E, Guelrud M et al. Functional gallbladder and sphincter of Oddi disorders. Gastroenterology 2006; 130: 1498-1509
    CrossrefPubMedGoogle Scholar
  • 2 Varadarajulu S, Hawes RH. Key issues in sphincter of Oddi dysfunction. Gastrointest Endosc Clin North Am 2003; 13: 671-694
    CrossrefPubMedGoogle Scholar
  • 3 Sherman S, Lehman GA. Sphincter of Oddi dysfunction: diagnosis and treatment. J Pancreas 2001; 2: 382-400
    PubMedGoogle Scholar
  • 4 Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004; 59: 845-864
    CrossrefPubMedGoogle Scholar
  • 5 Masci E, Mariani A, Curioni S et al. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy 2003; 35: 830-834
    Article in Thieme ConnectPubMedGoogle Scholar
  • 6 Fogel EL, 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
  • 7 Cotton PB, Durkalski V, Romagnuolo J et al. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA 2014; 311: 2101-2109
    CrossrefPubMedGoogle Scholar
  • 8 Cotton PB, Durkalski V, Orrell K et al. Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. Gastrointest Endosc 2010; 72: 986-991
    CrossrefPubMedGoogle Scholar
  • 9 Romagnuolo J, Cotton PB, Durkalski V et al. Can patient and pain characteristics predict manometric sphincter of Oddi dysfunction in patients with clinically suspected sphincter of Oddi dysfunction?. Gastrointest Endosc 2014; 79: 765-767
    CrossrefPubMedGoogle Scholar
  • 10 Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
    CrossrefPubMedGoogle Scholar
  • 11 Cohen S, Bacon BR, Berlin JA et al. National Institutes of Health State-of-the-Science Conference statement: ERCP for diagnosis and therapy. Gastrointest Endosc 2002; 56: 803-809
    CrossrefPubMedGoogle Scholar
  • 12 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
    CrossrefPubMedGoogle Scholar
  • 13 Yaghoobi M, Rolland S, Waschke KA et al. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther 2013; 38: 995-1001
    CrossrefPubMedGoogle Scholar
  • 14 Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
    CrossrefPubMedGoogle Scholar
  • 15 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
    CrossrefPubMedGoogle Scholar
  • 16 Saad AM, Fogel EL, McHenry L et al. Pancreatic duct stent placement prevents post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction but normal manometry results. Gastrointest Endosc 2008; 67: 255-261
    CrossrefPubMedGoogle Scholar
  • 17 Tarnasky PR, Simien M, Mehraban N et al. Selective avoidance of pancreatic duct manipulation decreases the need for repeat ERCP and lowers the risk in patients with unexplained upper abdominal pain: a single-center long-term study. Gastrointest Endosc 2012; 75: AB306-AB307
    PubMedGoogle Scholar