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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Drotaverine hydrochloride |
|
| 2 | Active Comparator | Hyoscine-N-butylbromide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drotaverine hydrochloride | Drug | Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cannulation Time | Intra-procedure | |
| Percentage of Successful Selective Cannulation | Intra-procedure | |
| Frequency of Post-ERCP Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, MD | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Fuzhou | China | ||||
| The First People's Hospital of Hangzhou |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Drotaverine hydrochloride |
| FG001 | Active Comparator | Hyoscine-N-butylbromide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Hyoscine-N-butylbromide | Drug | Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP. |
|
|
| 48 hours after ERCP |
| Side Effects | Intra-procedure and 24 hours after ERCP |
| Hangzhou |
| China |
| Heilongjiang Provincial Hospital | Harbin | China |
| Changhai Hospital, Second Military Medical University | Shanghai | China |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Drotaverine hydrochloride |
| BG001 | Active Comparator | Hyoscine-N-butylbromide |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | scores on a scale | Intra-procedure |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Cannulation Time | Not Posted | Intra-procedure | ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Successful Selective Cannulation | Not Posted | Intra-procedure | ||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Post-ERCP Complications | Not Posted | 48 hours after ERCP | ||||||||||||||||||||||||||||||||||||
| Secondary | Side Effects | Not Posted | Intra-procedure and 24 hours after ERCP |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Drotaverine hydrochloride | 0 | 319 | 0 | 319 | ||
| EG001 | Active Comparator | Hyoscine-N-butylbromide | 0 | 319 | 0 | 319 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li M.D. | Changhai Hospital, Second Military Medical University, Shanghai, China | 86-21-81873271 | zhaoshenlismmu@gmail.com |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| C005317 | drotaverin |
| D002086 | Butylscopolammonium Bromide |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| >=65 years |
|
| Male |
|