NCT00164853

Brief Summary

To compare the technique of combined balloon sphincter dilation after an initial sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct stones. The investigators hypothesize that combined balloon dilation and sphincterotomy allows for easier stone removal without added morbidities when compared to standard sphincterotomy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

February 17, 2012

Status Verified

September 1, 2010

Enrollment Period

6 years

First QC Date

September 11, 2005

Last Update Submit

February 16, 2012

Conditions

Common Bile Duct Stone

Outcome Measures

Primary Outcomes (1)

  • stone clearance rate at the index session

    The ability to achieve complete stone clearance on the first ERCP

    24 hours

Secondary Outcomes (2)

  • Number of ERCP's required to achieve stone clearance

    3 months

  • ERCP related complications

    30 days

Study Arms (2)

Standard sphincterotomy (ES)

ACTIVE COMPARATOR

After deep cannulation, a pull-type sphincterotomy will be performed with a 25mm sphincterotome (eg clever cut, Olympus, Tokyo, Japan) with division of sphincter up to the duodenal wall. A complete sphincterotomy is defined by the free passage of a fully bowed sphincterotome with a 25m wire and spontaneous bile drainage.

Procedure: Standard sphincterotomy

Sphincterotomy plus balloon dilation (ESBD)

ACTIVE COMPARATOR

After complete sphincterotomy, a 3-cm long 15mm diameter CRE balloon is passed over a guidewire across the lower end of common bile duct. The contrast filled balloon is inflated to the size of the bile duct for around 30 seconds until waisting is abolished.

Procedure: endoscopic balloon dilatation

Interventions

endoscopic balloon dilatationPROCEDURE

Refer to description under arms

Sphincterotomy plus balloon dilation (ESBD)
Standard sphincterotomyPROCEDURE

Refer to under arms

Standard sphincterotomy (ES)

Eligibility Criteria

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

You may qualify if:

  • Patients at least 18 years old, presented to Prince of Wales Hospital for endoscopic retrograde cholangiopancreatography (ERCP) for known or suspected bile duct stones are invited to participate.
  • Informed consent will be obtained before the beginning of ERCP.
  • Patients are randomized to EST or ESBD after confirming the presence of bile duct stones on the initial cholangiogram

You may not qualify if:

  • septic shock, coagulopathy (international normalized ratio \>1.3,
  • partial thromboplastin time greater than twice that of control),
  • platelet count \<50,000x103/uL or
  • ampullary tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (1)

  • Teoh AYB, Cheung FKY, Hu B, Pan YM, Lai LH, Chiu PWY, Wong SKH, Chan FKL, Lau JYW. Randomized trial of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for removal of bile duct stones. Gastroenterology. 2013 Feb;144(2):341-345.e1. doi: 10.1053/j.gastro.2012.10.027. Epub 2012 Oct 17.

    PMID: 23085096DERIVED

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frances KY Cheung, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2011

Last Updated

February 17, 2012

Record last verified: 2010-09

Locations

CN(1)