Clinical trial NCT00731198: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: ERCP
Pancreatic Diseases
Bile Duct Diseases
Keywords: ERCP
Drotaverine hydrochloride
Hyoscine-N-butylbromide
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The Grades of the Number of Duodenal Contractions
timeFrame: Intra-procedure
Secondary outcomes:
measure: Cannulation Time
timeFrame: Intra-procedure
measure: Percentage of Successful Selective Cannulation
timeFrame: Intra-procedure
measure: Frequency of Post-ERCP Complications
timeFrame: 48 hours after ERCP
measure: Side Effects
timeFrame: Intra-procedure and 24 hours after ERCP
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
city: Harbin
country: China
facility: Heilongjiang Provincial Hospital
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References: