Role of EUS in High Risk of Choledocholithiasis

Woo Hyun Paik

Status: Completed

Conditions: Choledocholithiasis

Treatments: Device: ERCP; Device: EUS

Study type: Interventional

Funder types: Other

Identifiers

NCT03250286

1705-070-854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abdominal CT or US showed a common bile duct diameter > 6mm (>8mm in patients with previous cholecystectomy) and elevated total bilirubin from 1.8mg/dL to less than 4.0mg/dL

Exclusion criteria

• Severe mental illness
• Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
• Pregnancy
• Pancreatic cancer or suspected malignant tumor of the biliary tract
• Acute pancreatitis
• Patient who has confirmed biliary stones in abdominal ultrasonography or CT
• Severe cholangitis according to TG 18 guideline
• Total bilirubin > 4mg/dL
• Patients who have difficulty with EUS or ERCP due to previous gastric surgery (Billroth II or TG with R-en-Y)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

EUS-ERCP group

Experimental group

Description:

EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.

Treatment:

Device: EUS

Device: ERCP

ERCP group

Active Comparator group

Description:

ERCP without EUS is performed in all patients.

Treatment:

Device: ERCP