Role of EUS in High Risk of Choledocholithiasis
Primary Purpose
Choledocholithiasis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS
ERCP
Sponsored by
About this trial
This is an interventional treatment trial for Choledocholithiasis
Eligibility 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)
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EUS-ERCP group
ERCP group
Arm Description
EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.
ERCP without EUS is performed in all patients.
Outcomes
Primary Outcome Measures
Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure
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 Outcome Measures
Length of hospital stay
Length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03250286
Brief Title
Role of EUS in High Risk of Choledocholithiasis
Official Title
Role of EUS in High Risk of Choledocholithiasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Woo Hyun Paik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS-ERCP group
Arm Type
Experimental
Arm Description
EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.
Arm Title
ERCP group
Arm Type
Active Comparator
Arm Description
ERCP without EUS is performed in all patients.
Intervention Type
Device
Intervention Name(s)
EUS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ERCP
Intervention Description
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 Measure Information:
Title
Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure
Description
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
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
6 months after randomization
Other Pre-specified Outcome Measures:
Title
The rate of diagnostic ERC (Endoscopic retrograde cholangiography)
Description
The diagnostic ERC was defined as any ERC procedures in which no stone or sludge was removed during the procedure.
Time Frame
6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Hyun Paik, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20105473
Citation
ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
Results Reference
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PubMed Identifier
28174126
Citation
He H, Tan C, Wu J, Dai N, Hu W, Zhang Y, Laine L, Scheiman J, Kim JJ. Accuracy of ASGE high-risk criteria in evaluation of patients with suspected common bile duct stones. Gastrointest Endosc. 2017 Sep;86(3):525-532. doi: 10.1016/j.gie.2017.01.039. Epub 2017 Feb 4.
Results Reference
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PubMed Identifier
18226685
Citation
Tse F, Liu L, Barkun AN, Armstrong D, Moayyedi P. EUS: a meta-analysis of test performance in suspected choledocholithiasis. Gastrointest Endosc. 2008 Feb;67(2):235-44. doi: 10.1016/j.gie.2007.09.047.
Results Reference
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PubMed Identifier
17478348
Citation
Garrow D, Miller S, Sinha D, Conway J, Hoffman BJ, Hawes RH, Romagnuolo J. Endoscopic ultrasound: a meta-analysis of test performance in suspected biliary obstruction. Clin Gastroenterol Hepatol. 2007 May;5(5):616-23. doi: 10.1016/j.cgh.2007.02.027.
Results Reference
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PubMed Identifier
27080611
Citation
De Castro VL, Moura EG, Chaves DM, Bernardo WM, Matuguma SE, Artifon EL. Endoscopic ultrasound versus magnetic resonance cholangiopancreatography in suspected choledocholithiasis: A systematic review. Endosc Ultrasound. 2016 Mar-Apr;5(2):118-28. doi: 10.4103/2303-9027.180476.
Results Reference
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PubMed Identifier
17427065
Citation
Polkowski M, Regula J, Tilszer A, Butruk E. Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies. Endoscopy. 2007 Apr;39(4):296-303. doi: 10.1055/s-2007-966264.
Results Reference
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PubMed Identifier
25792387
Citation
Adams MA, Hosmer AE, Wamsteker EJ, Anderson MA, Elta GH, Kubiliun NM, Kwon RS, Piraka CR, Scheiman JM, Waljee AK, Hussain HK, Elmunzer BJ. Predicting the likelihood of a persistent bile duct stone in patients with suspected choledocholithiasis: accuracy of existing guidelines and the impact of laboratory trends. Gastrointest Endosc. 2015 Jul;82(1):88-93. doi: 10.1016/j.gie.2014.12.023. Epub 2015 Mar 16.
Results Reference
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Role of EUS in High Risk of Choledocholithiasis
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