Comparison of Papillary Balloon Dilatation Vs.Sphincterotomy for Lithotripsy in Difficult Sphincterotomy or Distal CBD Tapering

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00329888
First received: May 24, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Comparison of Endoscopic Papillary Balloon Dilatation and Sphincterotomy for CBD Stones With Difficult Sphincterotomy or Distal CBD Tapering

Resource links provided by NLM:


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
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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.

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

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

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

ClinicalTrials.gov processed this record on October 23, 2014