Back to resultsDrotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Primary Purpose
ERCP, Pancreatic Diseases, Bile Duct Diseases
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Drotaverine hydrochloride
Hyoscine-N-butylbromide
Sponsored by
About this trial
This is an interventional prevention trial for ERCP focused on measuring ERCP, Drotaverine hydrochloride, Hyoscine-N-butylbromide
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 < 100 mmHg)
- Second-degree and third-degree atrioventricular block
- Heart failure
- Glaucoma
- Obstructive uropathy
- Impaired renal function (serum creatinine > 133μmol/L)
- Pregnant or breastfeeding women
Sites / Locations
- Fujian Provincial Hospital
- The First People's Hospital of Hangzhou
- Heilongjiang Provincial Hospital
- Changhai Hospital, Second Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Drotaverine hydrochloride
Hyoscine-N-butylbromide
Outcomes
Primary Outcome Measures
The Grades of the Number of Duodenal Contractions
a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
Secondary Outcome Measures
Cannulation Time
Percentage of Successful Selective Cannulation
Frequency of Post-ERCP Complications
Side Effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00731198
Brief Title
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems.
Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP.
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. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERCP, Pancreatic Diseases, Bile Duct Diseases
Keywords
ERCP, Drotaverine hydrochloride, Hyoscine-N-butylbromide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
650 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Drotaverine hydrochloride
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hyoscine-N-butylbromide
Intervention Type
Drug
Intervention Name(s)
Drotaverine hydrochloride
Other Intervention Name(s)
No-spa
Intervention Description
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Intervention Type
Drug
Intervention Name(s)
Hyoscine-N-butylbromide
Other Intervention Name(s)
Scopolamine Butylbromide
Intervention Description
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Primary Outcome Measure Information:
Title
The Grades of the Number of Duodenal Contractions
Description
a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
Time Frame
Intra-procedure
Secondary Outcome Measure Information:
Title
Cannulation Time
Time Frame
Intra-procedure
Title
Percentage of Successful Selective Cannulation
Time Frame
Intra-procedure
Title
Frequency of Post-ERCP Complications
Time Frame
48 hours after ERCP
Title
Side Effects
Time Frame
Intra-procedure and 24 hours after ERCP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 < 100 mmHg)
Second-degree and third-degree atrioventricular block
Heart failure
Glaucoma
Obstructive uropathy
Impaired renal function (serum creatinine > 133μmol/L)
Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Provincial Hospital
City
Fuzhou
Country
China
Facility Name
The First People's Hospital of Hangzhou
City
Hangzhou
Country
China
Facility Name
Heilongjiang Provincial Hospital
City
Harbin
Country
China
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
We'll reach out to this number within 24 hrs