NCT00451581

Brief Summary

Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 23, 2007

Status Verified

October 1, 2006

First QC Date

March 22, 2007

Last Update Submit

March 22, 2007

Conditions

Choledocholithiasis

Keywords

Endoscopic papillary balloon dilatationEndoscopic sphincterotomyCholedocholithiasisEfficacyComplication

Outcome Measures

Primary Outcomes (1)

  • need of switching to sphincterotomy

Secondary Outcomes (2)

  • efficacy of lithotripsy

  • post-ERCP complications

Interventions

Endoscopic papillary balloon dilation-5 minutesPROCEDURE
Endoscopic papillary balloon dilation-1 minutePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis

You may not qualify if:

  • Consent not obtained.
  • No apparent stone.
  • Intradiverticular papilla.
  • Prior EST.
  • Bile duct stricture.
  • Pancreatic or biliary malignant disorders.
  • Intrahepatic stones.
  • Active acute pancreatitis.
  • Sphincter of Oddi dysfunction.
  • Pregnancy.
  • Primary sclerosing cholangitis or choledochocyst.
  • Previous biliary surgery other than cholecystectomy.
  • Stone impaction at ampulla.
  • Precut for cannulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • 1. 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 bileduct stones. Lancet 1997;349:1124-9. 2. 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. 3. Lin CK, Lai KH, Chan HH, Tsai WL, Wang EM, Wei MC, Fu MT, Lo CC, Hsu PI, Lo GH. Endoscopic balloon dilatation is a safe method in the management of common bile duct stones. Dig Liver Dis 2004;36:68-72.

    BACKGROUND

  • Liao WC, Lee CT, Chang CY, Leung JW, Chen JH, Tsai MC, Lin JT, Wu MS, Wang HP. Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. Gastrointest Endosc. 2010 Dec;72(6):1154-62. doi: 10.1016/j.gie.2010.07.009. Epub 2010 Sep 25.

    PMID: 20869710DERIVED

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Officials

  • Wei-Chih Liao, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Chih Liao, MD

CONTACT

886-2-23123456david.ntuh@msa.hinet.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

January 1, 2007

Study Completion

January 1, 2008

Last Updated

March 23, 2007

Record last verified: 2006-10

Locations

TW(1)