Long-term Complications in Patients With Previous Endoscopic Papillary Large Balloon Dilation: a Nationwide Retrospective Study
Endoscopic retrograde cholangiopancreatography (ERCP) using standard techniques successfully removes common bile duct stones in most cases, but in 10-15% of patients, complex stone features or challenging biliary anatomy require advanced methods such as Endoscopic Papillary Large Balloon Dilation (EPLBD). Although EPLBD effectively facilitates the removal of difficult stones, it disrupts the papillary orifice and removes the natural barrier between the duodenum and the biliary tract, potentially increasing the risk of bacterial translocation and ascending cholangitis. This study aims to evaluate the long-term outcomes (over one year) in patients undergoing EPLBD, focusing primarily on the incidence of post-procedure cholangitis and secondarily on the rate of recurrent choledocholithiasis.
Study Overview
Status
Conditions
Detailed Description
Common bile duct stones are still the most common indication for endoscopic retrograde cholangiopancreatogrphy (ERCP). In the majority of cases bile duct clearance is obtained with standard techniques such as the execution of endoscopic sphincterotomy and the use of baskets and balloon catheters for bile duct stones extraction. In up to 10-15% of the cases, conventional techniques are unsuccessful defining the condition of difficult bile duct stones. The reason for a failed bile stones extraction is usually related to specific stone characteristics such as size, number, shape, consistency, location of the stone or certain biliary anatomy (biliary variants, altered anatomy intrahepatic locations of the stones, impacted stone). In these situations, the standard ERCP techniques for stones extraction could not be sufficient and advanced techniques are needed in order to obtain bile duct clearance. These includes endoscopic papillary large balloon dilation (EPLBD), mechanical lithotripsy and/or cholangioscopic-assisted lithotripsy. EPLBD is performed with a balloon catheter at the level of the papilla Balloon dilation allows a controlled dilation of the papilla and a subsequent extraction of the stones with the standard extraction devices. It demonstrated in different studies a high efficacy for difficult bile duct extraction compared to endoscopic sphincterotomy alone. EPLBD cause a complete disruption of the papilla orifice with a significant open communication between the duodenal lumen and the biliary tract. The absence of an anatomical barrier between the bile tract and the duodenal lumen could cause the translocation of intestinal bacteria and/or contamination with food particles with the potential risk of ascending cholangitis.
Aim of our study is to evaluate the natural history of patients who underwent to EPLBD especially focused on the appearance of cholangitis and bile duct stones relapse during a long-term follow-up (> 1 year). The primary objective is to evaluate the incidence of cholangitis episodes after EPLBD during a follow-up period of at least of 1 year. The secondary objective is to evaluate choledocholithiasis recurrence during a follow-up period of at least 1 year.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andrea Anderloni, MD
- Phone Number: +39 0382503370
- Email: a.anderloni@smatteo.pv.it
Study Locations
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Pavia
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Pavia, Pavia, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Contact:
- Andrea Anderloni, MD
- Phone Number: 0382503370
- Email: a.anderloni@smatteo.pv.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with an indication for ERCP for difficult bile stones in 15% of cases and application of EPLBD in 80% of cases.
Description
Inclusion Criteria:
- All patients with a diagnosis of choledocholithiasis who underwent ERCP with EPLBD from January 2014 to March 2023 with complete bile duct stone clearance in one or multiple ERCP sessions will be included in the study.
Exclusion Criteria:
- Patients with age less than 18 years old or with surgically altered anatomy or with orthotopic liver transplantation will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: RETROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of cholangitis
Time Frame: 12 months
|
evaluate the incidence of cholangitis episodes after EPLBD during a follow-up period of at least of 1 year. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of ERCP
Time Frame: 12 months
|
1-year cumulative incidence of ERCP performed for bile duct stones relapse. |
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wide
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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