Phase 3
N=650
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
ERCP · Pancreatic Diseases · Bile Duct Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00731198 ↗Enrolled (actual)
650
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: The Grades of the Number of Duodenal Contractions — 1.13; 1.17 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Drotaverine hydrochloride (Drug); Hyoscine-N-butylbromide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Changhai Hospital
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Grades of the Number of Duodenal Contractions |
1.13; 1.17 | — |
| SECONDARY Cannulation Time |
— | — |
| SECONDARY Percentage of Successful Selective Cannulation |
— | — |
| SECONDARY Frequency of Post-ERCP Complications |
— | — |
| SECONDARY Side Effects |
— | — |
Summary
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
Eligibility Criteria
Inclusion Criteria
- All patients undergoing ERCP above the age of 18 years
Exclusion Criteria
- Patient with Billroth II gastrectomy
- Known previous sphincterotomy
- Active acute pancreatitis before ERCP
- Ongoing acute cholangitis before ERCP
- Hypotension (systolic blood pressure 133μmol/L)
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT00731198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.