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

Choledocholithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00451581
• Other study ID #: 9561709036
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2007
• Last updated: March 22, 2007
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: October 2006
• Source: National Taiwan University Hospital
• Contact: Wei-Chih Liao, MD
• Phone: 886-2-23123456
• Email: david.ntuh[@]msa.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choledocholithiasis

Intervention

Procedure:
• Endoscopic papillary balloon dilation-5 minutes

• Endoscopic papillary balloon dilation-1 minute

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	need of switching to sphincterotomy
Secondary	efficacy of lithotripsy
Secondary	post-ERCP complications