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Research funded by the National Institute of Health/NIDDK
Funded by the NIH/NIDDK

Publications resulting from this study

Effect of Endoscopic Sphincterotomy for Suspected Sphincter of Oddi Dysfunction on Pain-Related Disability Following Cholecystectomy: The EPISOD Randomized Clinical Trial. (JAMA. 2014;311(20):2101-2109. doi:10.1001/jama.2014.5220)

http://jama.jamanetwork.com/article.aspx?articleid=1874513

The EPISOD Randomized Clinical Trial

1. The development and validation of the RAPID pain-burden instrument

(Durkalski V, Stewart W, MacDougall P, et al.)

Measuring episodic abdominal pain and disability in suspected sphincter of Oddi dysfunction. (World J Gastroenterol 2010;16:4416-21).

2.  The development of the design of the study

(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: 986-91).    

3. BaBaseline psychosocial demographics

(Brawman-Mintzer O, Cotton PB, Durkalski V et al.)

Psychosocial characteristics and pain burden of patients with suspected sphincter of Oddi dysfunction (SOD) in the EPISOD trial. (Am J Gastroenterol. 2014;109: 436-442).

4.    The clinical predictors of the results of sphincter manometry, in press

(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 Endoscop 2014 epub)

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This study is no longer accepting patients. Results are being analyzed, and will be published in spring/summer 2014

A publication of the results of this study can be found here.

A Clinical Research Trial listed on clinicaltrials.gov

Protocol Title: Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction(SOD) Acronym EPISOD.

Clinical Trial Phase: Phase III
Study Sites; Eight clinical centers in US
Study Period Planned enrollment period – 3 years
Planned duration of the study – 5 years
Study Population SOD Patients

Primary Study Objective: To ascertain whether subjects with SOD respond to sphincterotomy

Secondary Study Objectives:
To evaluate:

  • the association between the results of Sphincter of Oddi Manometry (SOM) (abnormal/normal) and the primary outcome (success/failure);
  •  the success rate (as defined in the primary) of subjects who receive biliary sphincterotomy alone versus subjects who receive both biliary and pancreatic sphincterotomy in the subgroup of patients with manometrically proven hypertension of the pancreatic sphincter;
  • the effects of pre-specified prognostic factors on the primary outcome;
  •  anxiety and depression scores over time and their relation to study outcomes;
  • the economic impact of SOD, and of endoscopic sphincterotomy in patients with SOD;

 

Primary Eligibility Criteria:

  • 18 – 65 years of age
  • Must have had your gallbladder removed
  • Can not have had prior ERCP treatment
  • Meet all other criteria listed here