Please assess the completion status of the following clinical trial:

Trial Title: Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Patients diagnosed with the clinical syndrome of SOD, as defined by the Modified Functional Biliary Disorders Module of the Rome III criteria~2. Pain burden of Grade 3 or higher on RAPID Questionnaire.~3. Cholecystectomy more than 90 days before enrollment.~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 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.~5. Normal abdominal imaging by CT or MR/MRCP with bile duct reported at ≤9mm.~6. Upper endoscopy examination without findings to explain the pain.~7. Pain persisting despite a one trial of acid suppressant medications for one month (if tolerated).~8. Pain persisting despite a trial of antispasmodics.~9. Subjects on antidepressants for pain control (not required) should be taking them for a minimum of one month prior to the baseline assessment.~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.~10.Access to a telephone. 11.Must be able to speak, read, and write English. 12.Signed and dated informed consent.~Exclusion Criteria:~1. Prior ERCP treatment.~2. Age \< 18 or Age \> 65.~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).~4. Prior gastric resection or surgery involving biliary diversion.~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.~6. Daily use of prescription analgesics over the previous month.~7. Abdominal discomfort every day for the past month at level of 3 or more on a scale of 1-10.~8. Presence of significant psychiatric disorders:~   1. Lifetime psychotic disorders, bipolar disorder;~  2. Substance use disorders within 6 months;~  3. Eating disorders within 2 years~  4. Moderate \& severe depression defined by BDI-II (Beck Depression Inventory) cutoff scores \>22 (unless receiving stable psychiatric therapy for six weeks); and/or,~  5. 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.~9. 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.~10. Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.~ERCP Criteria:~1. Pancreas divisum (complete or partial) (known or discovered at study ERCP).~2. Any pathology found at ERCP (except sphincter hypertension).~3. Failed pancreatic manometry.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 65 Years
- Healthy Volunteers: f

Study Arms:
- 1.ERCP with sphincterotomy (Type: ACTIVE_COMPARATOR): ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
- 2.ERCP without sphincterotomy (Type: PLACEBO_COMPARATOR): ERCP without cutting the biliary sphincter muscle (sphincterotomy)

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete