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

Bile Duct Diseases Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882451
• Other study ID #: ERCP-02
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2016
• Last updated: June 9, 2017
• Start date: July 2016
• Est. completion date: October 2017

Study information

• Verified date: June 2017
• Source: Changhai Hospital
• Contact: Shu-Ling Wang, M.D
• Phone: 021-81873241
• Email: wangshuling0000[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases

Intervention

Dietary Supplement:
• pinaverium bromide

• Vitamin C

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cannulation time for deep bile duct cannulation and pancreatic duct cannulation		2 days
Secondary	bile juice flow from the major papilla and pancreatic juice flow from the major papilla		2 days
Secondary	appearance of the major papillary orifice		2 days