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

Not Applicable

• Conditions: Bile Duct Diseases
• Interventions: Dietary Supplement: pinaverium bromide; Dietary Supplement: Vitamin C

• Registration Number: NCT02882451
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12
• Primary Completion: 2017-08
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pinaverium bromide	pinaverium bromide	take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally
Vitamin C	Vitamin C	take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally

Primary Outcome Measures

Name	Time	Method
cannulation time for deep bile duct cannulation and pancreatic duct cannulation	2 days

Secondary Outcome Measures

Name	Time	Method
appearance of the major papillary orifice	2 days
bile juice flow from the major papilla and pancreatic juice flow from the major papilla	2 days

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China