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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bile Duct Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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pinaverium bromide

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

Group Type EXPERIMENTAL

pinaverium bromide

Intervention Type DIETARY_SUPPLEMENT

Vitamin C

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

Group Type PLACEBO_COMPARATOR

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

Interventions

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pinaverium bromide

Intervention Type DIETARY_SUPPLEMENT

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes