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

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00329888
• Other study ID #: 9561703024
• Status: Active, not recruiting
• Phase: N/A
• First received: May 24, 2006
• Last updated: May 24, 2006
• Start date: March 2006
• Est. completion date: May 2006

Study information

• Verified date: April 2006
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• Endoscopic papillary balloon dilatation

• Endoscopic sphincterotomy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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.