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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
168
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGHangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe 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
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