A Phase III Randomized Multicenter Clinical Trial of Sphincterotomy for the Treatment of SOD III Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Success
研究概览
简要总结
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.
详细描述
Clinical Trial Phase: Phase III
Study Sites Seven clinical centers in US
Study Period Planned enrollment period - 3 years
Planned duration of the study - 5 years
Study Population SOD III Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •Prior ERCP treatment.
- •Age < 18 or Age >
- •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-
- •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.
- •ERCP Criteria:
- •Pancreas divisum (complete or partial) (known or discovered at study ERCP).
- •Any pathology found at ERCP (except sphincter hypertension).
- •Failed pancreatic manometry.
研究组 & 干预措施
1.ERCP with sphincterotomy
ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
干预措施: ERCP with sphincterotomy (Procedure)
2.ERCP without sphincterotomy
ERCP without cutting the biliary sphincter muscle (sphincterotomy)
干预措施: ERCP without sphincterotomy (Procedure)
结局指标
主要结局
Percentage of Participants With Success
时间窗: 1 year
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.
次要结局
- Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.(1 year)
研究者
Peter Cotton
Study Chair
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)