An interventional study of EPLBD and ELPBD+ESD in Choledocholithiasis, sponsored by Jianfeng Yang. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by Jianfeng Yang · Not applicable, Interventional, and Treatment
Endoscopic papillary balloon dilation (EPBD) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (EST) especially in cases of small stones. With larger stones (> 10 mm), EPBD with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ML). The present study aims to compare the efficacy and safety of limited EST plus endoscopic papillary balloon dilation (EST-EPBD) with endoscopic papillary large balloon dilation for large choledocholithiasis.
ERCP is the best option to remove bile duct stones. It can be done by either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). Large bile duct stones appear to be more difficult to remove with conventional methods, such as EST and EPBD. Therefore, extraction of large bile duct stones may require mechanical lithotripsy (ML) as an adjunctive procedure. The primary complication of ML is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. Some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (EPLBD) alone or combined with limited EST, establishing it as a safe treatment for the removal of large bile duct stones. The investigators conducted the present study to compare the therapeutic outcome and complications between EPLBD alone and limited EST plus EPLBD for the treatment of large bile duct stones.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 168 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →This is the only study on the registry with Jianfeng Yang as lead sponsor.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Endoscopic papillary large balloon dilation to extract bile duct stones
Procedure: EPLBD
Endoscopic papillary large balloon dilation combined with limited endoscopic sphincterotomy to extract bile duct stones
Procedure: ELPBD+ESD
Endoscopic papillary large balloon dilation for Choledocholithiasis
Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis
The incidence of complications
The incidence of complications
Time frame: within 1 months after the procedure
The success rate of 1st session treatment
The success rate of 1st session treatment
Time frame: within 1 months after the procedure
The rate of mechanical lithotripsy
The rate of mechanical lithotripsy
Time frame: within 1 months after the procedure
Total ercp times
Total ercp numbers
Time frame: within 1 months after the procedure
Overall successful stone removal rate
Overall successful stone removal rate
Time frame: within 1 months after the procedure
Plan to share: No
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