Plain English Summary
Background and study aims
Bile stones are small stones that form in the gallbladder and become lodged in the bile duct, causing pain. Endoscopic sphincterotomy followed by balloon dilation is a promising treatment for patients with large stones, multiple stones, and narrowing or twisting of the bile duct. Endoscopic sphincterotomy is an operation that uses a catheter (tube) and a wire to remove the bile stones. Balloon dilation uses a catheter with an inflatable balloon to widen the bile duct. However, there are no data on the ideal duration of balloon dilation. The aim of this study is to compare the effectiveness and complications of 30 or 60 seconds of balloon dilation after endoscopic sphincterotomy.
Who can participate?
Patients with bile stones that are 12 mm or wider that cannot be extracted using a standard balloon catheter in the bile duct
What does the study involve?
Participants are randomly allocated to undergo endoscopic sphincterotomy followed by either 30 or 60 seconds of balloon dilation. The effectiveness of the operation and complications are compared between the two groups.
What are the possible benefits and risks of participating?
No benefits are expected for patients participating in the study. The risks include pancreatitis (inflammation of the pancreas) and bleeding.
Where is the study run from?
Venizelio Hospital (Greece)
When is the study starting and how long is it expected to run for?
September 2009 to October 2011
Who is funding the study?
Venizelio Hospital (Greece)
Who is the main contact?
Dr Gregorios Paspatis
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol number from ethical committee: 5334
Study information
Scientific title
A randomized comparison of 60-seconds versus 30-seconds endoscopic balloon dilation after endoscopic sphincterotomy for the management of bile duct stones
Acronym
Study hypothesis
We assumed that increase in duration of balloon dilation from 30 to 60 sec offers an increase from 70% to 90% clearance of the bile ducts between the two groups at the 5% level of significance.
Ethics approval
Not provided at time of registration
Study design
Randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Bile duct stones
Intervention
Full length endoscopic sphincterotomy (ES) followed by 60-seconds versus 30-seconds balloon dilation (BD) for cases with large unretrieved stones, multiple stones and tapering or tortuosity of distal common bile duct.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Our data showed that 30-sec BD after ES for the management of bile duct stones was equally effective as 60-sec. Therefore, there is no need to exceed 30 seconds when removing stones from bile ducts with balloon dilation.
Secondary outcome measures
Study showed that the rate of post-procedure complications was not different between the two groups
Overall trial start date
01/09/2009
Overall trial end date
01/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with bile duct stones≥ 12mm (transverse diameter of the largest stone) that could not be extracted using a standard balloon catheter in the common bile duct
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124 patients
Participant exclusion criteria
1. Need for needle knife pre-cutting
2. Selective bile duct cannulation achieved after more than two accidental pancretograms or more than two insertions of the guidewire in the pancreatic duct
3. Cases with bleeding tendency (taking anticoagulant therapy, platelet count of less than 100.000/mm3, or prothrombin time more than 30% above the control
4. Billroth II or Roux-en Y reconstruction
5. Bile duct stones with diameter ≥20mm
6. Strictures
7. Patients undergoing anticoagulant or antiplatelet therapy for non-critical problems, such as cardiovascular and cerebral disorders, were instructed to discontinue the use of these types of medication at least 7 days before the endoscopic procedure
Recruitment start date
01/09/2009
Recruitment end date
01/10/2011
Locations
Countries of recruitment
Greece
Trial participating centre
Leoforos Knossou
Heraklion
71409
Greece
Funders
Funder type
Hospital/treatment centre
Funder name
Venizelio Hospital (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary