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Role of EUS in High Risk of Choledocholithiasis

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ClinicalTrials.gov Identifier: NCT03250286
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Woo Hyun Paik, Seoul National University Hospital

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 diagnostic yield of EUS in the diagnosis of choledocholithiasis.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Device: EUS Device: ERCP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of EUS in High Risk of Choledocholithiasis
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: EUS-ERCP group
EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.
Device: EUS

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.


Device: ERCP

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.

Active Comparator: ERCP group
ERCP without EUS is performed in all patients.
Device: ERCP

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 Outcome Measures :
  1. False negative (EUS) [ Time Frame: 6 months after randomization ]
    False negative of EUS for choledocholithiasis

  2. False negative (ERCP) [ Time Frame: 6 months after randomization ]
    False negative of ERCP for choledocholithiasis

  3. Complication (EUS) [ Time Frame: 6 months after randomization ]
    EUS related complications

  4. Complication (ERCP) [ Time Frame: 6 months after randomization ]
    ERCP related complications


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 6 months after randomization ]
    Length of hospital stay

  2. Sensitivity of EUS for choledocholithiasis [ Time Frame: 2 years ]
    Sensitivity of EUS in the diagnosis of choledocholithiasis

  3. Specificity of EUS for choledocholithiasis [ Time Frame: 2 years ]
    Specificity of EUS in the diagnosis of choledocholithiasis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250286


Contacts
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Contact: Young Hoon Choi, MD 82-2-2072-2228 crzyzs@naver.com
Contact: Woo Hyun Paik, MD, PhD 82-2-2072-2228 iatrus@hanmail.net

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Woo Hyun Paik, MD, PhD    82-2-2072-2228    iatrus@hanmail.net   
Sponsors and Collaborators
Woo Hyun Paik
Investigators
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Principal Investigator: Woo Hyun Paik, MD, PhD Seoul National University Hospital

Publications:

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Responsible Party: Woo Hyun Paik, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03250286     History of Changes
Other Study ID Numbers: 1705-070-854
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis