Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Pancreatic Diseases Clinical Trial

Official title:

Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731198
• Other study ID #: Changhai-080615
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2008
• Last updated: August 31, 2010
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: November 2009
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bile Duct Diseases
• ERCP
• Pancreatic Diseases

Intervention

Drug:
• Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
• Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou
China	The First People's Hospital of Hangzhou	Hangzhou
China	Heilongjiang Provincial Hospital	Harbin
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Intra-procedure	No
Secondary	Cannulation Time		Intra-procedure	No
Secondary	Percentage of Successful Selective Cannulation		Intra-procedure	No
Secondary	Frequency of Post-ERCP Complications		48 hours after ERCP	Yes
Secondary	Side Effects		Intra-procedure and 24 hours after ERCP	Yes