Study 7 of 8 for search of: "Choledocholithiasis"
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Comparison of Papillary Balloon Dilatation Vs.Sphincterotomy for Lithotripsy in Difficult Sphincterotomy or Distal CBD Tapering
This study is ongoing, but not recruiting participants.
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00329888
  Purpose

Compare endoscopic papillary balloon dilatation vs. endoscopic sphincterotomy for bile duct stones in:

  • when sphincterotomy is difficult (periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis)
  • when there is distal CBD tapering.

Condition Intervention
Choledocholithiasis
 Procedure: Endoscopic papillary balloon dilatation
Procedure: Endoscopic sphincterotomy

MedlinePlus related topics: Endoscopy
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Retrospective Study
Official Title: Comparison of Endoscopic Papillary Balloon Dilatation and Sphincterotomy for CBD Stones With Difficult Sphincterotomy or Distal CBD Tapering

Further study details as provided by National Taiwan University Hospital:

Study Start Date: March 2006
Estimated Study Completion Date: May 2006
Detailed Description:

Endoscopic papillary balloon dilatation is an alternative to endoscopic sphincterotomy for treating bile duct stones:

  • easier and as effective. But...
  • a higher risk of pancreatitis.

Conditions including periampullary diverticulum, prior EST, Billroth-II anastomosis, or distal CBD tapering pose difficulty in EST and lithotripsy with increased risk of complications.

Whether EPBD or EST is superior in efficacy or safety under such circumstances is not clear.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Choledocholithiasis with
  • Difficult sphincterotomy:periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis
  • or distal CBD tapering.

Exclusion Criteria:

  • Patients in whom no endoscopic papillary balloon dilatation or endoscopic sphincterotomy was performed for lithotripsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329888

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

Publications:
1. Minami A, Nakatsu T, Uchida N, Hirabayashi S, Fukuma H, Morshed SA, Nishioka M. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. Dig Dis Sci 1995;40:2550-4. 2. 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 bile duct stones. Lancet 1997;349:1124-9. 3.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. 4. Fujita N, Maguchi H, Komatsu Y, Yasuda I, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K, Maeshiro K. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc 2003;57:151-5.

Study ID Numbers: 9561703024
Study First Received: May 24, 2006
Last Updated: May 24, 2006
ClinicalTrials.gov Identifier: NCT00329888  
Health Authority: Taiwan: Department of Health

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

Study placed in the following topic categories:
Cholecystolithiasis
Cholelithiasis
Digestive System Diseases
Dilatation, Pathologic
Gallstones
 Bile Duct Diseases
Biliary Tract Diseases
Calculi
Choledocholithiasis

Additional relevant MeSH terms:
Common Bile Duct Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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