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.
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) 1.3.1 Treatment of SOD is being disputed: currently, the main method is to relax sphincter of Oddi (SO). * Medications: antispasmodic drugs, nitrates, calcium ion antagonists, modulators of gastrointestinal (GI) motility * EST(endoscopic sphincterotomy): postoperative complications and mortality 1.3.2 EST is not well effective in the treatment of SOD type II and type III, which are mostly caused by functional abnormalities -ASGE guideline 2015 points out that EST is not recommended for patients with SOD type III. Endoscopic stents are not recommended, either. 1.3.3 Danshu Capsules: contains the active pharmaceutical ingredient (API) and has the effects of fighting infection, alleviating pain, promoting bile secretion and lifting muscle spasms; literature showed that Danshu Capsules effectively improved the symptoms of biliary disorders, such as pain, nausea and abdominal distension. 1.3.4 Pinaverium Bromide: able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.·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.
Danshu Capsules (0.9g potid/day) for three months by oral
Pinaverium Bromide (100mg potid/day) for three months by oral
Zhang Yong
Shanghai, Shanghai Municipality, China
RECRUITINGEfficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication
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
Time frame: Change From Baseline to 3 Months After Medication
Changes in the Common Bile Duct (CBD) Diameter Measured by Ultrasound B Once a Month
Changes in the CBD diameter measured by ultrasound B * Each patient is required to abstain from eating for 12 hours and then takes a measurement of the CBD diameter by ultrasound B the next morning * The measurement takes places once a month, four times totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)
Time frame: Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)
Efficacy of Lowering Liver Enzymes as Assessed by Laboratory Test Once a Month
* Changes in hepatic enzyme levels (ALT, AST and ALP) * The measurement takes place once a month, four times totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)
Time frame: Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)
Number of Participants With Treatment-Related Diarrhea,Change From Baseline to 3 Months After Medication
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
The number of patients presenting the symptoms of diarrhea will be calculated at the time of enrollment (baseline) and 3 months after treatment respectively.
Time frame: From Baseline to 3 Months After Medication