Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography

Naval Military Medical University

Status: Unknown

Conditions: Bile Duct Diseases

Treatments: Dietary Supplement: Vitamin C; Dietary Supplement: pinaverium bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT02882451

ERCP-02

Details and patient eligibility

About

Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS) and functional disorders of the biliary tract. In this study, pinaverium bromide was compared with Vitamin C for the facilitation of bile duct and pancreatic duct cannulation in patients. The primary outcome was successful deep bile duct cannulation and pancreatic duct canulation. The second outcome was the major papillary orifice,bile juice flow from the papilla, time to achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the pinaverium bromide group versus Vitamin C group.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. those with intact native papilla,
2. who underwent endoscopic retrograde choledochopancreatography for bile duct,
3. age≥18 years, ≤80years, and
4. agreement to participate in the study.

Exclusion criteria

1. a previous sphincterotomy,
2. previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation,
3. indwelling biliary or pancreatic stent(s),
4. active acute pancreatitis,
5. active acute pancreatitis
6. altered/postsurgical anatomy,
7. history of gastroparesis,
8. endoscopic retrograde choledochopancreatography for sphincter of Oddi's sphincter(SO) manometry,
9. known tumor of the major duodenal papilla, and
10. patients with any medication probably affecting SO motility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

pinaverium bromide

Experimental group

Description:

take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally

Treatment:

Dietary Supplement: pinaverium bromide

Vitamin C

Placebo Comparator group

Description:

take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally

Treatment:

Dietary Supplement: Vitamin C