No Value to Sphincterotomy in Sphincter of Oddi Dysfunction Type III: Long-Term Follow-Up The EPISOD study: long-term outcomes.Cotton PB, Pauls Q, Keith J, Thornhill A, Drossman D, Williams A, Durkalski-Mauldin V. Gastrointest Endosc. 2017 Apr 25. [Epub ahead of print]

BACKGROUND AND AIMS:The EPISOD (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction) study randomized subjects with post-cholecystectomy pain, and little or no objective evidence for biliary obstruction, to sphincterotomy or sham intervention. Results at 1 year showed no benefit for the active treatment. We now report the outcomes at up to 5 years.

METHODS:103 subjects completing 1 year, and still blinded to treatment allocation, were enrolled and followed by phone every 6 months for a median of 58 months (range 17-71). Their success was assessed at final visit by 2 criteria: (1) a low pain score (RAPID <6) and (2) much or very much improved on the PGIC questionnaire (both with no repeat intervention and not taking narcotics).RESULTS:By RAPID criteria, success rates for the subjects in the sphincterotomy and sham arms were similar: 26/65 (40%) versus 16/38 (42%), respectively. However, by PGIC criteria, actively treated subjects fared worse: 16/43 (37%) versus 16/22 (73%). A total of 75 subjects underwent active treatment during the entire study. Their success rate by RAPID criteria was 31 (41%), compared with 16 (62%) who had no active treatment at any time.CONCLUSIONS:These data confirm our initial report that endoscopic sphincterotomy is no better than sham intervention in these patients (and, by some criteria, worse), and that ERCP can no longer be recommended. The patients have genuine and often severe symptoms, and further research is needed to establish effective management.

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