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Status unknownNCT00329888Updated May 25, 2006

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

An observational study in Choledocholithiasis, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2006-05-25.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Defined population
Time perspective
Other
Ages
0 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Choledocholithiasis

Keywords

  • Endoscopic papillary balloon dilatation
  • Endoscopic sphincterotomy
03

In context

Choledocholithiasis

104 studies on the registry are indexed under Choledocholithiasis; 23 are open to participants now.

Browse Choledocholithiasis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients in whom no endoscopic papillary balloon dilatation or endoscopic sphincterotomy was performed for lithotripsy
05

Study design

Observational model
Defined population
Time perspective
Other

Interventions

  • ProcedureEndoscopic papillary balloon dilatation
  • ProcedureEndoscopic sphincterotomy
06

Study locations

1 site
  • National Taiwan University Hospital
    Taipei City, 100, Taiwan
07

References and documents

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.
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00329888
Lead sponsor
National Taiwan University Hospital
First posted
May 25, 2006
Start date
Mar 2006
Completion
May 2006
Last update
May 25, 2006

Study contacts

Wei Chih Liao, MD.
principal investigator · National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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