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A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00451581
First received: March 22, 2007
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.


Condition Intervention
Choledocholithiasis
 Procedure: Endoscopic papillary balloon dilation-5 minutes
Procedure: Endoscopic papillary balloon dilation-1 minute

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • need of switching to sphincterotomy

Secondary Outcome Measures:
  • efficacy of lithotripsy
  • post-ERCP complications

Estimated Enrollment: 160
Study Start Date: January 2007
Estimated Study Completion Date: January 2008
Detailed Description:

Endoscopic papillary balloon dilatation (EPBD) has been proposed as an alternative to endoscopic sphincterotomy (EST) for endoscopic treatment of common bile duct (CBD) stones. EPBD is as effective as EST in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of Oddi. However, it has been reported that about 20% of patients undergoing EPBD need EST as a rescue procedure for lithotripsy. A longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to EST.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis

Exclusion Criteria:

  • Consent not obtained.
  • No apparent stone.
  • Intradiverticular papilla.
  • Prior EST.
  • Bile duct stricture.
  • Pancreatic or biliary malignant disorders.
  • Intrahepatic stones.
  • Active acute pancreatitis.
  • Sphincter of Oddi dysfunction.
  • Pregnancy.
  • Primary sclerosing cholangitis or choledochocyst.
  • Previous biliary surgery other than cholecystectomy.
  • Stone impaction at ampulla.
  • Precut for cannulation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451581

Contacts
Contact: Wei-Chih Liao, MD 886-2-23123456 ext 3356 david.ntuh@msa.hinet.net

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Principal Investigator: Wei-Chih Liao, MD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wei-Chih Liao, MD National Taiwan University Hospital
  More Information

Publications:
1. Bergman JJ, Rauws EA, Fockens P, van Berkel AM, Bossuyt PM, Tijssen JG, Tytgat GN, Huibregtse K. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones. Lancet 1997;349:1124-9. 2. Komatsu Y, Kawabe T, Toda N, Ohashi M, Isayama M, Tateishi K, Sato S, Koike Y, Yamagata M, Tada M, Shiratori Y, Yamada H, Ihori M, Kawase T, Omata M. Endoscopic papillary balloon dilation for the management of common bile duct stones: experience of 226 cases. Endoscopy 1998;30:12-7. 3. Lin CK, Lai KH, Chan HH, Tsai WL, Wang EM, Wei MC, Fu MT, Lo CC, Hsu PI, Lo GH. Endoscopic balloon dilatation is a safe method in the management of common bile duct stones. Dig Liver Dis 2004;36:68-72.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00451581     History of Changes
Other Study ID Numbers: 9561709036
Study First Received: March 22, 2007
Last Updated: March 22, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Endoscopic papillary balloon dilatation
Endoscopic sphincterotomy
Choledocholithiasis
Efficacy
Complication

Additional relevant MeSH terms:
Dilatation, Pathologic
Choledocholithiasis
Pathological Conditions, Anatomical
Common Bile Duct Diseases
 Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis

ClinicalTrials.gov processed this record on May 16, 2013