Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study
NCT ID: NCT05191693
Last Updated: 2022-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
72 participants
OBSERVATIONAL
2018-09-30
2020-08-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
NCT02330601
A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation
NCT00451581
Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones
NCT02592811
ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP
NCT02830984
Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications
NCT02510495
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Overall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST. The mean CBD diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). Post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. Mild cholangitis occurred in two cases. No cases with perforation or PEP were observed. During a mean follow-up of 22.4±6.2 months (range 13-36), CBD stones recurred in 2/72 (2.7%).
EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (\<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patients with CBD stones up to 8-12mm
72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST
ERCP
endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ERCP
endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Venizelio General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gregorios Paspatis
director of the gastroenterology department of Venizelio General Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gregorios Gregorios, Director
Role: STUDY_DIRECTOR
''Benizelion" General Hospital, Heraklion, Crete
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
''Benizelion" General Hospital
Heraklion, , Greece
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Paspatis-balloon dilation
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.