search
Back to results

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

Primary Purpose

Bile Duct Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pinaverium bromide
Vitamin C
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Diseases focused on measuring bile duct, endoscopic retrograde cholangiopancreatography, pinaverium bromide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Changhai Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pinaverium bromide

Vitamin C

Arm Description

take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally

take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally

Outcomes

Primary Outcome Measures

cannulation time for deep bile duct cannulation and pancreatic duct cannulation

Secondary Outcome Measures

bile juice flow from the major papilla and pancreatic juice flow from the major papilla
appearance of the major papillary orifice

Full Information

First Posted
July 22, 2016
Last Updated
June 9, 2017
Sponsor
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02882451
Brief Title
Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Diseases
Keywords
bile duct, endoscopic retrograde cholangiopancreatography, pinaverium bromide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pinaverium bromide
Arm Type
Experimental
Arm Description
take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally
Arm Title
Vitamin C
Arm Type
Placebo Comparator
Arm Description
take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally
Intervention Type
Dietary Supplement
Intervention Name(s)
pinaverium bromide
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Primary Outcome Measure Information:
Title
cannulation time for deep bile duct cannulation and pancreatic duct cannulation
Time Frame
2 days
Secondary Outcome Measure Information:
Title
bile juice flow from the major papilla and pancreatic juice flow from the major papilla
Time Frame
2 days
Title
appearance of the major papillary orifice
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Ling Wang, M.D
Phone
021-81873241
Email
wangshuling0000@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Bai, M.D
Phone
021-81873241
Email
baiyu1998@hotmail.com
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
Phone
86-21-81873241
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs