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Status unknownNCT02882451Updated Jun 12, 2017

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

An interventional study of pinaverium bromide and Vitamin C in Bile Duct Diseases, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bile Duct Diseases

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Keywords

  • bile duct
  • endoscopic retrograde cholangiopancreatography
  • pinaverium bromide
03

In context

Bile Duct Diseases

56 studies on the registry are indexed under Bile Duct Diseases; 16 are open to participants now.

This study's planned enrollment of 200 is above the median of 93 across 34 interventional studies indexed under Bile Duct Diseases.

Browse Bile Duct Diseases studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

Interventions

  • Dietary supplementpinaverium bromide
  • Dietary supplementVitamin C
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What researchers measure

Primary outcomes

  1. cannulation time for deep bile duct cannulation and pancreatic duct cannulation

    Time frame: 2 days

Secondary outcomes

  1. bile juice flow from the major papilla and pancreatic juice flow from the major papilla

    Time frame: 2 days

  2. appearance of the major papillary orifice

    Time frame: 2 days

07

Study locations

1 of 1 sites recruiting
  • Changhai Hospital, Second Military Medical University
    Shanghai, 200433, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02882451
Lead sponsor
Changhai Hospital
Responsible party
Zhaoshen Li (Head of Digestive Endoscopy Center, Changhai Hospital) — Principal investigator
First posted
Aug 29, 2016
Start date
Jul 2016
Primary completion
Aug 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Jun 12, 2017

Study contacts

Shu-Ling Wang, M.D
Contact
wangshuling0000@126.com
021-81873241
Yu Bai, M.D
Contact
baiyu1998@hotmail.com
021-81873241

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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