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Completed

NCT Number: NCT03250286

Role of EUS in High Risk of Choledocholithiasis

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.

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Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EUS

Device

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.

ERCP

Device

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.

Primary outcomes

  1. Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure

    Time frame: 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 outcomes

  1. Length of hospital stay

    Time frame: 6 months after randomization

    Length of hospital stay

Other outcomes

  1. The rate of diagnostic ERC (Endoscopic retrograde cholangiography)

    Time frame: 6 months after randomization

    The diagnostic ERC was defined as any ERC procedures in which no stone or sludge was removed during the procedure.

Sponsors and collaborators

Lead sponsor

Woo Hyun Paik

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2017
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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