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Recruiting NCT07932275

Long-term Complications in Patients With Previous Endoscopic Papillary Large Balloon Dilation: a Nationwide Retrospective Study

Conditions: Endoscopic Papillary Large Balloon Dilation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Location: Fondazione IRCCS Policlinico San Matteo di Pavia Pavia Pavia

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07932275). StuddyBuddy aggregates publicly available trial information.