The EPISOD study: long-term outcomes

Cotton_headshotPost written by Peter B. Cotton, MD, FRCS, FRCP, from the Medical University of South Carolina, Charleston, South Carolina, USA.

The EPISOD study randomized 214 patients with post-cholecystectomy pain and little or no evidence of biliary obstruction (SOD type III) to sphincterotomy or sham intervention at ERCP. Intervention was judged successful at 1 year (by reduction in the RAPID pain/burden score) in only a third of patients, and active treatment was no better than sham. Sphincter manometry was not predictive of the outcome. This study followed 103 of the patients (still blinded to their treatment allocation) for 5 years. At 5 years, the success of actively treated and sham-treated patients was the same  (40% and 42%) by the RAPID criteria. However, by the PGIC (Patients Global Impression of Change) criteria, sham-treated patients did better (73% vs 37%). These data confirm that ERCP intervention has no merit in patients with post-cholecystectomy pain and little or no evidence of biliary obstruction and should be avoided. The term “SOD type III” should be abandoned.

Similar stringent research is needed in other contexts where sphincter dysfunction is suspected, ie, SOD type II (post-cholecystectomy pain with a dilated bile duct or elevated liver enzymes) and Idiopathic recurrent acute pancreatitis.


Read the full article online.

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