NCT00329888

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
Last Updated

May 25, 2006

Status Verified

April 1, 2006

First QC Date

May 24, 2006

Last Update Submit

May 24, 2006

Conditions

Keywords

Endoscopic papillary balloon dilatationEndoscopic sphincterotomy

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Sphincterotomy, Endoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeEndoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyMinimally Invasive Surgical ProceduresSphincterotomyMyotomy

Study Officials

  • Wei Chih Liao, MD.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2006

First Posted

May 25, 2006

Study Start

March 1, 2006

Study Completion

May 1, 2006

Last Updated

May 25, 2006

Record last verified: 2006-04

Locations