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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00329888
Recruitment Status : Unknown
Verified April 2006 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 25, 2006
Last Update Posted : May 25, 2006
Information provided by:
National Taiwan University Hospital

Brief Summary:

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 or disease Intervention/treatment
Choledocholithiasis Procedure: Endoscopic papillary balloon dilatation Procedure: Endoscopic sphincterotomy

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.

Study Type : Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Comparison of Endoscopic Papillary Balloon Dilatation and Sphincterotomy for CBD Stones With Difficult Sphincterotomy or Distal CBD Tapering
Study Start Date : March 2006
Estimated Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00329888

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

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
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: May 25, 2006
Last Verified: April 2006

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

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