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
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
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
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
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
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