Choledocholithiasis
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEEUS
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.
DEVICEERCP
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.
Sponsors
Woo Hyun Paik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure | 6 months after randomization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 6 months after randomization | Length of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| The rate of diagnostic ERC (Endoscopic retrograde cholangiography) | 6 months after randomization | The diagnostic ERC was defined as any ERC procedures in which no stone or sludge was removed during the procedure. |
Countries
South Korea
Outcome results
None listed