Condition category
Digestive System
Date applied
21/05/2012
Date assigned
09/07/2012
Last edited
22/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Gregorios Paspatis

ORCID ID

Contact details

Leoforos Knossou
PO Box 1044
Heraklion
71409
Greece

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

Sponsor information

Organisation

Venizelio Hospital (Greece)

Sponsor details

Leoforos Knossou
P.O. BOX 1044
Heraklion
71409
Greece

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

22/09/2016: Plain English summary added.