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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02882451

Enrollment

200

Registered

2016-08-29

Start date

2016-07-31

Completion date

2017-10-31

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Diseases

Keywords

bile duct, endoscopic retrograde cholangiopancreatography, pinaverium bromide

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.

Interventions

DIETARY_SUPPLEMENTpinaverium bromide

DIETARY_SUPPLEMENTVitamin C

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
cannulation time for deep bile duct cannulation and pancreatic duct cannulation	2 days

Secondary

Measure	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

Countries

China

Contacts

Primary ContactShu-Ling Wang, M.D

wangshuling0000@126.com021-81873241

Backup ContactYu Bai, M.D

baiyu1998@hotmail.com021-81873241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026