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

Phase 3

Completed

Conditions: Pancreatic Diseases
ERCP
Bile Duct Diseases

Interventions: Drug: Drotaverine hydrochloride
Drug: Hyoscine-N-butylbromide

Registration Number: NCT00731198

Lead Sponsor: Changhai Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 650

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Drotaverine hydrochloride	Drotaverine hydrochloride
2	Hyoscine-N-butylbromide	Hyoscine-N-butylbromide

Primary Outcome Measures

Name	Time	Method
The Grades of the Number of Duodenal Contractions	Intra-procedure	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

Name	Time	Method
Cannulation Time	Intra-procedure
Side Effects	Intra-procedure and 24 hours after ERCP
Percentage of Successful Selective Cannulation	Intra-procedure
Frequency of Post-ERCP Complications	48 hours after ERCP

Trial Locations

Locations (4): Changhai Hospital, Second Military Medical University
🇨🇳
Shanghai, China
Fujian Provincial Hospital
🇨🇳
Fuzhou, China
The First People's Hospital of Hangzhou
🇨🇳
Hangzhou, China
Heilongjiang Provincial Hospital
🇨🇳
Harbin, China