The EPISOD study: long-term outcomes - 21/06/18

Doi : 10.1016/j.gie.2017.04.015

Peter B. Cotton, MD, FRCS, FRCP ^1,^⁎, Qi Pauls, MS ², Jamila Keith, BS ³, Andre Thornhill, MS ⁴, Douglas Drossman, MD ⁵, April Williams, BS ³, Valerie Durkalski-Mauldin, MPH PhD ⁴
¹ Professor of Medicine, Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA
² Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA
³ Division of Gastroenterology and Hepatology, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA
⁴ Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA
⁵ Center for Functional GI and Motility Disorders at University of North Carolina and Drossman Gastroenterology, Chapel Hill, North Carolina, USA

^∗Reprint requests: Peter B. Cotton, MD, FRCS, FRCP, Professor of Medicine, Digestive Disease Center, Medical University of South Carolina, 114 Doughty Street, Suite 249, MSC 702, Charleston, SC 29425.Professor of MedicineDigestive Disease CenterMedical University of South Carolina114 Doughty Street, Suite 249, MSC 702CharlestonSC 29425

Abstract

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.)

Le texte complet de cet article est disponible en PDF.

Abbreviations : CI, EPISOD, HADS, PGIC, RAPID, SF-36, SOD

Plan

Introduction

Methods

Results

EPISOD randomized cohort

EPISOD 2

Discussion

	DISCLOSURE: This study was funded by grant U01 DK074739 from the National Institutes of Diabetes and Digestive and Kidney Diseases. All authors disclosed no financial relationships relevant to this publication.
	See CME section; p. 272.
	If you would like to chat with an author of this article, you may contact Professor Cotton at cottonp@musc.edu.