An observational study in Endoscopic Papillary Large Balloon Dilation, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
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.
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.
120 studies on the registry are indexed under Dilatation, Pathologic; 18 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 144 across 30 observational studies indexed under Dilatation, Pathologic.
Browse Dilatation, Pathologic studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 258 studies on the registry; 115 are open to participants now.
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Patients with an indication for ERCP for difficult bile stones in 15% of cases and application of EPLBD in 80% of cases.
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Incidence of cholangitis
evaluate the incidence of cholangitis episodes after EPLBD during a follow-up period of at least of 1 year.
Time frame: 12 months
Incidence of ERCP
1-year cumulative incidence of ERCP performed for bile duct stones relapse.
Time frame: 12 months
Ran from Jan 2025 to primary completion in Sep 2026, 20 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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