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

June 9, 2017 updated by: Zhaoshen Li, Changhai Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pinaverium bromide
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
Placebo Comparator: Vitamin C
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cannulation time for deep bile duct cannulation and pancreatic duct cannulation
Time Frame: 2 days
2 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERCP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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