Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction
Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction
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.
Inclusion Criteria:

 -  Chief complaint of upper right abdominal pain following LC (within 2 weeks to 6
 months) at a hospital visit, but not a pain caused by surgical incision, lasting 3 to
 5 minutes each time, without a history of other biliary tract operation

 -  No presence of intestinal obstruction as evidenced by plain abdominal X-ray, with
 peptic ulcer and duodenal diverticulum ruled out through barium meal examination or
 gastroscopy

 -  No other obvious abnormalities as evidenced by abdominal ultrasound B and MRCP, except
 for bile duct dilation

 -  Patients with biliary-type sphincter of Oddi dysfunction (SOD) who are classified as
 SOD type II (biliary-type abdominal pain accompanied by hepatic enzyme elevation or
 common bile duct (CBD) dilation) and SOD type III (only biliary-type abdominal pain)
 according to Geenen-Hogan classification criteria

 Exclusion Criteria:

 -  Postoperative biliary calculi, benign biliary stenosis, bile duct infection, overlong
 residual cystic duct (> 0.5cm), biliary tumors, etc.

 -  Peptic ulcer, duodenal diverticulum

 -  Pancreatitis, pancreatic-type SOD

 -  Adhesive intestinal obstruction

 -  Postoperative irritable bowel syndrome (IBS)

 -  A history of abdominal operation or other surgery

 -  Pregnant and lactating women

 -  Use of other drugs from one week after LC to enrollment, including antispasmodic
 drugs, analgesics, choleretic agents, calcium ion antagonists and GI motility drugs

 -  A history of allergy to Pinaverium Bromide / Danshu Tablets