A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation

A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00451581

Enrollment

160

Registered

2007-03-23

Start date

2007-01-31

Completion date

2008-01-31

Last updated

2007-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

Keywords

Endoscopic papillary balloon dilatation, Endoscopic sphincterotomy, Choledocholithiasis, Efficacy, Complication

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.

Detailed description

Endoscopic papillary balloon dilatation (EPBD) has been proposed as an alternative to endoscopic sphincterotomy (EST) for endoscopic treatment of common bile duct (CBD) stones. EPBD is as effective as EST in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of Oddi. However, it has been reported that about 20% of patients undergoing EPBD need EST as a rescue procedure for lithotripsy. A longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to EST.

Interventions

PROCEDUREEndoscopic papillary balloon dilation-5 minutes

PROCEDUREEndoscopic papillary balloon dilation-1 minute

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
need of switching to sphincterotomy	—

Secondary

Measure	Time frame
efficacy of lithotripsy	—
post-ERCP complications	—

Countries

Taiwan

Contacts

Primary ContactWei-Chih Liao, MD

david.ntuh@msa.hinet.net886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026