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

NCT ID: NCT00451581

Last Updated: 2007-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Choledocholithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Endoscopic papillary balloon dilation-5 minutes

Intervention Type: PROCEDURE

Endoscopic papillary balloon dilation-1 minute

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Wei-Chih Liao, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wei-Chih Liao, MD

Role: CONTACT

david.ntuh@msa.hinet.net

886-2-23123456 ext. 3356

References

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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 20869710 (View on PubMed)

Other Identifiers

9561709036

Identifier Type: -

Identifier Source: org_study_id