The aim of this study is to demonstrate that patients with high risk of choledocholithiasis who undergo ERCP only for patients with choledocholith in the EUS examination\[EUS-ERCP group\] have less negative outcomes (including false-negative results and procedure-related complications) than patients who undergo ERCP in all patients with high risk of choledocholithiasis\[ERCP group\]. The primary outcome is the incidence of negative outcomes (including false-negative results and procedure-related complications) in both groups. The secondary outcomes included days of hospitalization and the rate of diagnostic ERC.
Several studies have shown that EUS testing prior to ERCP may reduce ERCP complications in patients with intermediate-risk choledocholithiasis. In other words, this results obtained by not performing ERCP in patients without choledocholith in the EUS examination. However, to the best of our knowledge, no prospective study has been conducted on the role of EUS in patients with high risk of choledocholithiasis. Therefore, we investigate the role of EUS screening in patients with high risk of choledocholithiasis. We compare the negative outcomes (including false negative and procedure-related complications of EUS and ERCP) of the 'EUS-ERCP group' in which ERCP is performed when necessary after the EUS examination and the 'ERCP group' in which ERCP is performed in all patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Endoscopic ultrasound (EUS) is performed with radial scanning echo endoscope (Olympus GF UE260) by four endosonographers. EUS examination is performed first, and if there is choledocholith, ERCP is performed.
Endoscopic retrograde cholangiopancreatography (ERCP) is performed with duodenoscope (Olympus JF-260V or TJF-260V) by four endoscopists. * In the EUS-ERCP group, ERCP is used to remove bile duct stones diagnosed via EUS. Therefore, only ERCP is performed in patients with choledocholithiasis in EUS. * In the ERCP group, diagnosis and treatment of bile duct stones are performed with ERCP.
Seoul National University Hospital
Seoul, South Korea
Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure
Negative outcomes associated with a false-negative diagnosis of choledocholithiasis were defined as follows: 1) diagnosis of choledocholithiasis during follow-up or 2) hospitalization for a condition likely associated with choledocholithiasis, such as biliary pancreatitis, cholangitis, or obstructive jaundice. Negative outcomes of endoscopic procedures were assessed according to the ASGE lexicon
Time frame: 6 months after randomization
Length of hospital stay
Length of hospital stay
Time frame: 6 months after randomization
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