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

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ClinicalTrials.gov Identifier: NCT00451581
Recruitment Status : Unknown
Verified October 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 23, 2007
Last Update Posted : March 23, 2007
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
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 or disease Intervention/treatment
Choledocholithiasis Procedure: Endoscopic papillary balloon dilation-5 minutes Procedure: Endoscopic papillary balloon dilation-1 minute

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.
Study Start Date : January 2007
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Endoscopy
U.S. FDA Resources




Primary Outcome Measures :
  1. need of switching to sphincterotomy

Secondary Outcome Measures :
  1. efficacy of lithotripsy
  2. post-ERCP complications


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00451581     History of Changes
Other Study ID Numbers: 9561709036
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: March 23, 2007
Last Verified: October 2006

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

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