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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00731198
• Collaborator: (none)
• Enrollment: 650
• Locations: 4
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 162.5
• Patients Per Site Per Month: 14.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ERCP; Pancreatic Diseases; Bile Duct Diseases	Drug: Drotaverine hydrochloride; Drug: Hyoscine-N-butylbromide	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 650 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Drotaverine hydrochloride	Drug: Drotaverine hydrochloride; Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP; Other Names: No-spa
Active Comparator: 2 Hyoscine-N-butylbromide	Drug: Hyoscine-N-butylbromide; Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.; Other Names: Scopolamine Butylbromide

Outcome Measures

Primary Outcome Measures

1. 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

1. Cannulation Time [Intra-procedure]

2. Percentage of Successful Selective Cannulation [Intra-procedure]

3. Frequency of Post-ERCP Complications [48 hours after ERCP]

4. Side Effects [Intra-procedure and 24 hours after ERCP]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Provincial Hospital	Fuzhou		China
2	The First People's Hospital of Hangzhou	Hangzhou		China
3	Heilongjiang Provincial Hospital	Harbin		China
4	Changhai Hospital, Second Military Medical University	Shanghai		China

Sponsors and Collaborators

• Changhai Hospital

Investigators

• Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00731198
• Other Study ID Numbers: Changhai-080615
• First Posted: Aug 8, 2008
• Last Update Posted: Sep 8, 2010
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: ERCP; Drotaverine hydrochloride; Hyoscine-N-butylbromide
• Additional relevant MeSH terms: Pancreatic Diseases; Bile Duct Diseases; Drotaverin; Scopolamine; Butylscopolammonium Bromide

Study Results

Participant Flow

Arm/Group Title	Experimental	Active Comparator
Arm/Group Description	Drotaverine hydrochloride	Hyoscine-N-butylbromide
Period Title: Overall Study
STARTED	325	325
COMPLETED	319	319
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	Experimental	Active Comparator	Total
Arm/Group Description	Drotaverine hydrochloride	Hyoscine-N-butylbromide	Total of all reporting groups
Overall Participants	325	325	650
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	205 63.1%	197 60.6%	402 61.8%
>=65 years	120 36.9%	128 39.4%	248 38.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.98 (15.75)	59.20 (16.14)	58.09 (15.97)
Sex: Female, Male (Count of Participants)
Female	139 42.8%	173 53.2%	312 48%
Male	186 57.2%	152 46.8%	338 52%
Region of Enrollment (participants) [Number]
China	325 100%	325 100%	650 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental	Active Comparator
Arm/Group Description	Drotaverine hydrochloride	Hyoscine-N-butylbromide
Measure Participants	319	319
Mean (Standard Deviation) [scores on a scale]	1.13 (0.89)	1.17 (0.82)

2. Secondary Outcome

Title	Cannulation Time
Time Frame	Intra-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Percentage of Successful Selective Cannulation
Time Frame	Intra-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Frequency of Post-ERCP Complications
Time Frame	48 hours after ERCP

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Side Effects
Time Frame	Intra-procedure and 24 hours after ERCP

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Experimental		Active Comparator
Arm/Group Description	Drotaverine hydrochloride		Hyoscine-N-butylbromide
All Cause Mortality
	Experimental		Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Experimental		Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/319 (0%)		0/319 (0%)
Other (Not Including Serious) Adverse Events
	Experimental		Active Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/319 (0%)		0/319 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.