Bile Duct DiseasesNCT02882451
Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography
A study testing pinaverium bromide and Vitamin C in people with Bile Duct Diseases, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bile Duct Diseases
- What is being tested?
- pinaverium bromide and Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- those with intact native papilla,
- who underwent endoscopic retrograde choledochopancreatography for bile duct,
- age≥18 years, ≤80years, and
- agreement to participate in the study.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
zhaoshen Li, MD
About this study
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.
- Conditions
- Bile Duct Diseases
- Being tested
- pinaverium bromide, Vitamin C
- Keywords
- bile duct, endoscopic retrograde cholangiopancreatography, pinaverium bromide
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pinaverium bromideDietary supplement
Vitamin CDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| pinaverium bromide | Experimental | take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally Receives: Dietary Supplement: pinaverium bromide |
| Vitamin C | Placebo comparator | take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
cannulation time for deep bile duct cannulation and pancreatic duct cannulation
Measured: 2 days
Secondary outcomes (2)
bile juice flow from the major papilla and pancreatic juice flow from the major papilla
Measured: 2 days
appearance of the major papillary orifice
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882451
- Sponsor's protocol ID
- ERCP-02
- Status last verified
- Jun 2017
- First submitted
- 22 Jul 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pinaverium Bromide on Bile Duct and Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT02882451
- Acronym / sponsor ID
- ERCP-02
- Conditions
- Bile Duct Diseases
- Keywords
- bile duct, endoscopic retrograde cholangiopancreatography, pinaverium bromide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pinaverium bromide | Experimental | Dietary Supplement: pinaverium bromidetake 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally |
| Vitamin C | Placebo comparator | Dietary Supplement: Vitamin Ctake 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- those with intact native papilla,
- who underwent endoscopic retrograde choledochopancreatography for bile duct,
- age≥18 years, ≤80years, and
- agreement to participate in the study.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pinaverium bromide | Dietary supplement | pinaverium bromide |
| Vitamin C | Dietary supplement | Vitamin C |
Primary outcome
cannulation time for deep bile duct cannulation and pancreatic duct cannulation
Time frame: 2 days
2 secondary outcomes
bile juice flow from the major papilla and pancreatic juice flow from the major papilla
Time frame: 2 days
appearance of the major papillary orifice
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pinaverium bromide and Vitamin C in people with Bile Duct Diseases, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Ling Wang, M.D (021-81873241, wangshuling0000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cannulation time for deep bile duct cannulation and pancreatic duct cannulation (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.