Clinical Trial: Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Application of Pinaverium Bromide in the Treatment of Patients With Post-cholecystectomy Sphincter of Oddi Dysfunction (SOD): A Randomized, Controlled and Multicenter Clin

Brief Summary: Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of life (QoL).The primary objective of this trial is to evaluate the efficacy of relieving abdominal pain of Pinaverium Bromide in medication therapy for patients with post-cholecystectomy SOD.

Detailed Summary:

1.1 Background (I)

1.1.1 10%~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases;

1.1.2 Sphincter of Oddi dysfunction (SOD):

• It refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis.
• Pain caused by SOD affects the quality of life (QoL).

1.1.3 The diagnosis of SOD is still being disputed, and there has been no optimal solution so far.

• The diagnosis of SOD is largely based on clinical judgment
• The gold standards ERCP and SOM are invasive diagnostic criteria

1.2 Background (II)

1.2.1 If biliary-type abdominal pain after cholecystectomy is considered as SOD, most of the patients are classified as SOD II and SOD III according to Rome III Criteria-modified.

Biliary SOD Type I: moderate or severe biliary-type abdominal pain; transient ALT / AST/ALP elevation > 2ULN; CBD dilation > 8mm as evidenced by ultrasound or other non-invasive examination Type II: biliary-type abdominal pain; One or two of above items Type III:only biliary-type abdominal pain

1.3 Background (III)

abdominal pain scores (baseline vs. 3 months after treatment)

• Abdominal pain score based on main symptom: Degree of pain in point（0 - no pain [0 point]；1~3 - mild pain [1 point]；4~6 moderate pain [2 point]]；7~10 - severe pain [3 point]）、Frequency in times/week (No episodes[0 point]；1 time/week[1 point]；2 times/week[2 point]; 3 times/week[3 point])、Duration in days/week(No episodes[0 point]；< 1 day/week[1 point]；1-2days/week[2 points]；≥ 3days/week[3 points])
• The sum of the scores for the above three items is the total score for abdominal pain.
• Efficacy evaluation: reduction in abdominal pain score, as compared with the baseline
• = 100%: complete remission (CR)；60%~99%: significant remission (SR)；30% ~ 59%: partial remission (PR)；0% ~ 29%: no response (NR)
• Treatment response = CR + SR
• Treatment response rate = (CR + SR) / the total number of patients