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

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ClinicalTrials.gov Identifier: NCT00731198
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : December 23, 2009
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Changhai Hospital

Tracking Information
First Submitted Date  ICMJE August 6, 2008
First Posted Date  ICMJE August 8, 2008
Results First Submitted Date  ICMJE September 14, 2009
Results First Posted Date  ICMJE December 23, 2009
Last Update Posted Date September 8, 2010
Study Start Date  ICMJE August 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)		 The Grades of the Number of Duodenal Contractions [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)		 The number of duodenal contractions [ Time Frame: Intra-procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
  • Cannulation Time [ Time Frame: Intra-procedure ]
  • Percentage of Successful Selective Cannulation [ Time Frame: Intra-procedure ]
  • Frequency of Post-ERCP Complications [ Time Frame: 48 hours after ERCP ]
  • Side Effects [ Time Frame: Intra-procedure and 24 hours after ERCP ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
  • Cannulation time [ Time Frame: Intra-procedure ]
  • Percentage of successful selective cannulation [ Time Frame: Intra-procedure ]
  • Frequency of post-ERCP complications [ Time Frame: 48 hours after ERCP ]
  • Side effects [ Time Frame: Intra-procedure and 24 hours after ERCP ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title  ICMJE Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • ERCP
  • Pancreatic Diseases
  • Bile Duct Diseases
Intervention  ICMJE
  • Drug: Drotaverine hydrochloride
    Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
    Other Name: No-spa
  • Drug: Hyoscine-N-butylbromide
    Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
    Other Name: Scopolamine Butylbromide
Study Arms  ICMJE
  • Experimental: 1
    Drotaverine hydrochloride
    Intervention: Drug: Drotaverine hydrochloride
  • Active Comparator: 2
    Hyoscine-N-butylbromide
    Intervention: Drug: Hyoscine-N-butylbromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2009)		 650
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2008)		 1000
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00731198
Other Study ID Numbers  ICMJE Changhai-080615
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Zhaoshen Li, Changhai Hospital, Second Military Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Changhai Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhaoshen Li, MD Changhai Hospital
PRS Account Changhai Hospital
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP