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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 24, 2006

Last Updated Date

May 24, 2006

Start Date ^†

March 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Comparison of Endoscopic Papillary Balloon Dilatation and Sphincterotomy for CBD Stones With Difficult Sphincterotomy or Distal CBD Tapering

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.

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 Phase

Study Type ^†

Observational

Study Design ^†

Natural History, Cross-Sectional, Defined Population, Retrospective Study

Condition ^†

Choledocholithiasis

Intervention ^†

Procedure: Endoscopic papillary balloon dilatation
Procedure: Endoscopic sphincterotomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

May 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Taiwan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00329888

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

National Taiwan University Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Wei Chih Liao, MD.

National Taiwan University Hospital

Information Provided By

National Taiwan University Hospital

Verification Date

April 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.