Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

NCT00688662 | Completed Results DMC

• 2 other identifiers: DK074739U01DK074739
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 7

Brief Summary

The Evaluating Predictors \& Interventions in Sphincter of Oddi Dysfunction(SOD) study (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of Oddi dysfunction type III.

Conditions

Sphincter of Oddi Dysfunction

Keywords

Sphincter of Oddi Dysfunction; Pancreatitis; Sphincterotomy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Success

  The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of \<6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.

  1 year

Secondary Outcomes (1)

• Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.

  1 year

Study Arms (2)

1.ERCP with sphincterotomy

ACTIVE COMPARATOR

ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)

Procedure: ERCP with sphincterotomy

2.ERCP without sphincterotomy

PLACEBO COMPARATOR

ERCP without cutting the biliary sphincter muscle (sphincterotomy)

Procedure: ERCP without sphincterotomy

Interventions

ERCP with sphincterotomy PROCEDURE

cutting the biliary sphincter muscle (sphincterotomy)

1.ERCP with sphincterotomy

ERCP without sphincterotomy PROCEDURE

ERCP with sphincter manometry, but no sphincterotomy

2.ERCP without sphincterotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with the clinical syndrome of SOD, as defined by the Modified Functional Biliary Disorders Module of the Rome III criteria
• Pain burden of Grade 3 or higher on RAPID Questionnaire.
• Cholecystectomy more than 90 days before enrollment.
• Laboratory Tests: Results of blood tests taken within 1 week preceding the baseline visit and any others available from the preceding 6 months (post-cholecystectomy):Direct bilirubin, alkaline phosphatase, amylase and lipase results must be no greater than 2 X the upper level of normal.Transaminase levels can be no more than 3 X upper limit of normal. If the transaminases are elevated (\<2X ULN) in association with a pain attack, they cannot have returned to normal within 3 days.
• Normal abdominal imaging by CT or MR/MRCP with bile duct reported at ≤9mm.
• Upper endoscopy examination without findings to explain the pain.
• Pain persisting despite a one trial of acid suppressant medications for one month (if tolerated).
• Pain persisting despite a trial of antispasmodics.
• Subjects on antidepressants for pain control (not required) should be taking them for a minimum of one month prior to the baseline assessment.
• Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.
• Access to a telephone. 11.Must be able to speak, read, and write English. 12.Signed and dated informed consent.

You may not qualify if:

• Prior ERCP treatment.
• Age \< 18 or Age \> 65.
• Pregnancy: Women who are pregnant at the time of Screening\* will be excluded from the study. (\*Note: Women who become pregnant AFTER the Baseline Visit/ERCP will be allowed to remain in the study for telephone follow-up visits).
• Prior gastric resection or surgery involving biliary diversion.
• Prior diagnosis of acute pancreatitis (lipase \>3 x ULN) including post-ERCP pancreatitis, or of chronic pancreatitis by radiological imaging, EUS 5 or more criteria, or Cambridge criteria moderate or more on ERCP.
• Daily use of prescription analgesics over the previous month.
• Abdominal discomfort every day for the past month at level of 3 or more on a scale of 1-10.
• Presence of significant psychiatric disorders:
• Lifetime psychotic disorders, bipolar disorder;
• Substance use disorders within 6 months;
• Eating disorders within 2 years
• Moderate \& severe depression defined by BDI-II (Beck Depression Inventory) cutoff scores \>22 (unless receiving stable psychiatric therapy for six weeks); and/or,
• Suicidal risk (equal to or greater than "low") using MINI suicide section or a score of greater than 0 on question 9 of the BDI.
• The total number of days in the previous 3 months that the subject has taken prescription analgesics due to episodes of abdominal pain is greater than the total number of days the subject had episodes of abdominal pain.
• Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (7)

Yale University

New Haven, Connecticut, 06510, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55415, United States

Location

Midwest Therapeutic Endoscopy Consultants

St Louis, Missouri, 63141, United States

Location

Medical University of South Carolina Digestive Disease Center

Charleston, South Carolina, 29425, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• Yaghoobi M, Pauls Q, Durkalski V, Romagnuolo J, Fogel EL, Tarnasky PR, Aliperti G, Freeman ML, Kozarek RA, Jamidar PA, Wilcox CM, Elta GH, Hawes RH, Wood-Williams A, Cotton PB. Incidence and predictors of post-ERCP pancreatitis in patients with suspected sphincter of Oddi dysfunction undergoing biliary or dual sphincterotomy: results from the EPISOD prospective multicenter randomized sham-controlled study. Endoscopy. 2015 Oct;47(10):884-90. doi: 10.1055/s-0034-1392418. Epub 2015 Jul 10.

  PMID: 26165739 DERIVED

• Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, Aliperti G, Freeman M, Kozarek R, Jamidar P, Wilcox M, Serrano J, Brawman-Mintzer O, Elta G, Mauldin P, Thornhill A, Hawes R, Wood-Williams A, Orrell K, Drossman D, Robuck P. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA. 2014 May;311(20):2101-9. doi: 10.1001/jama.2014.5220.

  PMID: 24867013 DERIVED

• Romagnuolo J, Cotton PB, Durkalski V, Pauls Q, Brawman-Mintzer O, Drossman DA, Mauldin P, Orrell K, Williams AW, Fogel EL, Tarnasky PR, Aliperti G, Freeman ML, Kozarek RA, Jamidar PA, Wilcox CM, Serrano J, Elta GH. Can patient and pain characteristics predict manometric sphincter of Oddi dysfunction in patients with clinically suspected sphincter of Oddi dysfunction? Gastrointest Endosc. 2014 May;79(5):765-72. doi: 10.1016/j.gie.2013.11.037. Epub 2014 Jan 25.

  PMID: 24472759 DERIVED

• Cotton PB, Durkalski V, Orrell KB, Brawman-Mintzer O, Drossman DA, Wilcox CM, Mauldin PD, Elta GH, Tarnasky PR, Fogel EL, Jagganath SB, Kozarek RA, Freeman ML, Romagnuolo J, Robuck PR. Challenges in planning and initiating a randomized clinical study of sphincter of Oddi dysfunction. Gastrointest Endosc. 2010 Nov;72(5):986-91. doi: 10.1016/j.gie.2010.08.022.

  PMID: 21034899 DERIVED

MeSH Terms

Conditions

Sphincter of Oddi Dysfunction; Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Sphincterotomy

Condition Hierarchy (Ancestors)

Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Pancreatic Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Myotomy

Results Point of Contact

• Title: Dr Peter Cotton
• Organization: Medical University of South Carolina

cottonp@musc.edu

8438767217

Study Officials

• Joseph Romagnuolo, MD

  Medical Universtiy of South Carolina

  PRINCIPAL INVESTIGATOR

• Martin Freeman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Richard Kozarek, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

• Evan Fogel, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Peter Cotton, MD

  MUSC Digestive Disease Center

  STUDY CHAIR

• Paul Tarnasky, MD

  Digestive Health Associates of Texas

  PRINCIPAL INVESTIGATOR

• Giuseppe Aliperti, MD

  Midwest Therapeutic Endoscopy Consultants

  PRINCIPAL INVESTIGATOR

• Priya Jamidar, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Jose Serrano

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2016
• Last Updated: April 19, 2018
• Results First Posted: July 28, 2016

Record last verified: 2018-03

Locations

US (7)