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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03250286
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase N/A
Start date July 25, 2017
Completion date June 5, 2020

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