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

Study Overview
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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.

Conditions
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Bile Duct Diseases

Intervention / Treatment
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* Dietary Supplement: pinaverium bromide
* Dietary Supplement: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: those with intact native papilla, who underwent endoscopic retrograde choledochopancreatography for bile duct, age≥18 years, ≤80years, and agreement to participate in the study. Exclusion Criteria: a previous sphincterotomy, previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation, indwelling biliary or pancreatic stent(s), active acute pancreatitis, active acute pancreatitis altered/postsurgical anatomy, history of gastroparesis, endoscopic retrograde choledochopancreatography for sphincter of Oddi's sphincter(SO) manometry, known tumor of the major duodenal papilla, and patients with any medication probably affecting SO motility

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pinaverium bromide<br>take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally | Dietary Supplement: pinaverium bromide<br> <br> |
| Placebo Comparator: Vitamin C<br>take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally | Dietary Supplement: Vitamin C<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cannulation time for deep bile duct cannulation and pancreatic duct cannulation |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bile juice flow from the major papilla and pancreatic juice flow from the major papilla |  | 2 days | 
| appearance of the major papillary orifice |  | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bile duct, endoscopic retrograde cholangiopancreatography, pinaverium bromide