Comparison of 60-seconds versus 30-seconds endoscopic balloon dilation after endoscopic sphincterotomy for the management of bile duct stones

ISRCTN ISRCTN13081712
DOI https://doi.org/10.1186/ISRCTN13081712
Secondary identifying numbers Protocol number from ethical committee: 5334
Submission date
21/05/2012
Registration date
09/07/2012
Last edited
22/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Gregorios Paspatis
Scientific

Leoforos Knossou
PO Box 1044
Heraklion
71409
Greece

Study information

Study designRandomized study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA randomized comparison of 60-seconds versus 30-seconds endoscopic balloon dilation after endoscopic sphincterotomy for the management of bile duct stones
Study objectivesWe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBile duct stones
InterventionFull 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 typeProcedure/Surgery
Primary outcome measureOur 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 measuresStudy showed that the rate of post-procedure complications was not different between the two groups
Overall study start date01/09/2009
Completion date01/10/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants124 patients
Key inclusion criteriaPatients 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2009
Date of final enrolment01/10/2011

Locations

Countries of recruitment

  • Greece

Study participating centre

Leoforos Knossou
Heraklion
71409
Greece

Sponsor information

Venizelio Hospital (Greece)
Hospital/treatment centre

Leoforos Knossou
P.O. BOX 1044
Heraklion
71409
Greece

ROR logo "ROR" https://ror.org/043889z90

Funders

Funder type

Hospital/treatment centre

Venizelio Hospital (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

22/09/2016: Plain English summary added.