BACKGROUND:EUS is being increasingly utilized for the diagnosis of choledocholithiasis and microlithiasis, especially in patients with biliary colic. Simultaneously, there is also a rising interest in the use of EUS for therapeutic interventions. OBJECTIVES: Our goal was to assess the effectiveness of EUS-directed common bile duct (CBD) stone removal to compare its safety and effectiveness with ERCP-directed intervention. DESIGN: Interim results of a prospective, randomized, single-center blinded clinical trial. SETTING: A single tertiary care referral center. PATIENTS: Fifty-two patients with uncomplicated CBD stones were prospectively randomized to CBD cannulation and stone removal under EUS or ERCP guidance. MAIN OUTCOME MEASUREMENTS AND INTERVENTIONS: Primary outcome measure was the rate of successful cannulation of the CBD. Secondary outcome measures included successful removal of stones and overall complication rates. RESULTS: CBD cannulation followed by stone extraction was successful in 23 of 26 patients (88.5%) in the EUS group (I) versus 25 of 26 patients (96.2%) in the ERCP group (II) (95% CI, -27.65%, 9.88%). Overall, there were 3 complications in the EUS group and 4 complications in the ERCP group. LIMITATION: The current study is an interim report from a single center report and performed by a single operator. CONCLUSIONS: Our preliminary analysis indicates that outcomes following EUS-guided CBD stone retrieval are equivalent to those following ERCP. EUS-related adverse events are similar to those following ERCP. ERCP and EUS-guided stone retrieval appears to be equally effective for therapeutic interventions of the bile duct. Additional studies are required to validate these preliminary results and to determine predictors of success of EUS-guided stone removal.
RCT Entities:
BACKGROUND: EUS is being increasingly utilized for the diagnosis of choledocholithiasis and microlithiasis, especially in patients with biliary colic. Simultaneously, there is also a rising interest in the use of EUS for therapeutic interventions. OBJECTIVES: Our goal was to assess the effectiveness of EUS-directed common bile duct (CBD) stone removal to compare its safety and effectiveness with ERCP-directed intervention. DESIGN: Interim results of a prospective, randomized, single-center blinded clinical trial. SETTING: A single tertiary care referral center. PATIENTS: Fifty-two patients with uncomplicated CBD stones were prospectively randomized to CBD cannulation and stone removal under EUS or ERCP guidance. MAIN OUTCOME MEASUREMENTS AND INTERVENTIONS: Primary outcome measure was the rate of successful cannulation of the CBD. Secondary outcome measures included successful removal of stones and overall complication rates. RESULTS: CBD cannulation followed by stone extraction was successful in 23 of 26 patients (88.5%) in the EUS group (I) versus 25 of 26 patients (96.2%) in the ERCP group (II) (95% CI, -27.65%, 9.88%). Overall, there were 3 complications in the EUS group and 4 complications in the ERCP group. LIMITATION: The current study is an interim report from a single center report and performed by a single operator. CONCLUSIONS: Our preliminary analysis indicates that outcomes following EUS-guided CBD stone retrieval are equivalent to those following ERCP. EUS-related adverse events are similar to those following ERCP. ERCP and EUS-guided stone retrieval appears to be equally effective for therapeutic interventions of the bile duct. Additional studies are required to validate these preliminary results and to determine predictors of success of EUS-guided stone removal.
Authors: Everson L A Artifon; Eduardo B da Silveira; Dayse Aparicio; Jonas Takada; Renato Baracat; Christiano M Sakai; Ruel T Garcia; Vanessa Teich; Decio S Couto Journal: Dig Dis Sci Date: 2011-02-12 Impact factor: 3.199