The EPISOD study: long-term outcomes.

BACKGROUND AND AIMS

The EPISOD (Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction) study randomized patients 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

One hundred three patients 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 months). Their success was assessed at the final visit by 2 criteria: (1) a low pain score (Recurrent Abdominal Pain and Disability instrument [RAPID] <6) and (2) much or very much improved on the Patients' Global Impression of Change (PGIC) questionnaire (both with no repeat intervention and not taking narcotics).

RESULTS

By the RAPID criteria, success rates for the patients in the sphincterotomy and sham arms were similar: 26/65 (40%) versus 16/38 (42%), respectively. However, by the PGIC criteria, actively treated patients fared worse: 16/43 (37%) versus 16/22 (73%). A total of 75 patients underwent active treatment during the entire study. Their success rate by the 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. (Clinical trial registration number: 00688662 05/3/2008.).