Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)
Summary: SOD is a disorder that involves the circular muscle that surrounds the drainage hole through which bile and pancreatic juices flow from the liver and pancreas into the duodenum (small intestine). Some patients who have had their gall bladders removed (cholecystectomy) develop increased pressure in the sphincter muscle. This causes back up of bile and/or pancreatic juices, which results in attacks of abdominal pain.
ERCP (Endoscopic retrograde cholangio-pancreatography) is a standard (non-research) procedure commonly used to diagnose problems in the liver, gallbladder, bile ducts, and pancreas including SOD.
During ERCP, the doctor can also measure the pressure (squeeze) of the sphincter muscle. This is called sphincter of Oddi manometry (SOM). Patients with abnormal SOM pressure results are usually treated at the same time by cutting the sphincter muscle (sphincterotomy), so that it cannot go into spasm, in the hope of preventing further attacks of pain. As part of the procedure, a small plastic drainage tube (stent) is usually placed (temporarily) to improve drainage and prevent complications.
The main purpose of the EPISOD trial is to study whether sphincterotomy is effective and how well patients respond. Although ERCP, SOM, and sphincterotomy are all standard clinical procedures routinely performed in patients with SOD, there is no clear scientific data showing the effectiveness of sphincterotomy (how well it works in particular patients) or whether the pressure measurements (SOM) can predict how well patients will respond to the sphincterotomy.
| HR#: |
17712 |
| PRINCIPAL INVESTIGATOR: |
Peter Cotton, , MD, FRCP, FRCS |
| SPONSOR: |
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| TARGET ENROLLMENT: |
45 |
| DISEASE TYPE: |
S.O.D. |
| BODY LOCATION(S): |
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| PRIMARY OBJECTIVE: |
To ascertain whether subjects with SOD III respond to sphincterotomy |
| SECONDARY OBJECTIVE(S): |
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 III, and of endoscopic sphincterotomy in patients with SOD III; and, to,
• conduct a careful follow-up study (EPISOD2) of standard of care treatment (separate protocol).
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| INCLUSION CRITERIA: |
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1
| Patients diagnosed with the clinical syndrome of SOD, as defined by the Functional Biliary Disorders Module of the Rome III criteria. |
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2
| Grade 3 or higher on RAPID Questionnaire |
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3
| Prior cholecystectomy |
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4
| 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 within normal limits (WNL).? Transaminase levels can be no more than 2 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. |
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5
| Normal abdominal imaging by CT or MR/MRCP with bile duct reported at =9mm |
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6
| Upper endoscopy examination without findings to explain the pain. |
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7
| Pain persisting despite a one month trial of PPIs and PRN antispasmodics. |
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8
| Subjects on antidepressants for pain control (not required) should be taking them for a minimum of one month prior to the baseline assessment. |
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9
| Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks. |
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10
| Access to a telephone. |
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11
| Must be able to speak, read, and write English. |
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12
| Signed and dated informed consent. |
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13
| The total number of days in the previous 3 months that
the subject has taken prescription analgesics due to
episodes of abdominal pain is not greater than the total
number of days the subject had episodes of abdominal
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| EXCLUSION CRITERIA: |
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1
| Prior ERCP treatment. |
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2
| Age < 18 or Age > 65 |
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3
| 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). |
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4
| Prior gastric resection or surgery involving biliary diversion. |
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5
| 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. |
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6
| Daily use of prescription analgesics over the previous month. |
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7
| Abdominal discomfort every day for the past month at level of 3 or more on a scale of 1-10. |
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8
| Presence of significant psychiatric disorders:
a. Lifetime psychotic disorders, bipolar disorder;
b. Substance use disorders within 6 months;
c. Eating disorders within 2 years
d. Moderate & severe depression defined by BDI-2 cutoff scores >14 (Beck Depression Inventory); and,
e. Suicidal risk (more than “low”) using MINI suicide section or a score of greater than 0 on question 9 of the BDI.
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9
| Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation. |
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10
| Pancreas divisum (complete or partial) (known or
discovered at study ERCP).
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11
| Any pathology found at ERCP (except sphincter hypertension). |
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12
| Failed pancreatic manometry. |
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| TREATMENT GROUPS: |
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| LENGTH OF STUDY: |
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| CONTACTS: |
- Rebekah Whichard, , BA, CCRC (Primary Study Coordinator)
(843) 876-7233 or richreb@musc.edu
- Kyle Orrell, MSHP (DDC Research Program Manager)
843-876-4303 or orrell@musc.edu
- Peter Cotton, , MD, FRCP, FRCS (Principal Investigator)
(843) 876-7226 or cottonp@musc.edu
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