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CompletedNCT03250286Updated Mar 18, 2021

Role of EUS in High Risk of Choledocholithiasis

An interventional study of EUS and ERCP in Choledocholithiasis, sponsored by Woo Hyun Paik. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.

Sponsored by Woo Hyun Paik · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Choledocholithiasis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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 · Device: ERCP

  • Active comparator
    ERCP group

    ERCP without EUS is performed in all patients.

    Device: ERCP

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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months after randomization

Secondary outcomes

  1. Length of hospital stay

    Length of hospital stay

    Time frame: 6 months after randomization

Other outcomes

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

    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

06

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 20105473 ↗
  • 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. PubMed 28174126 ↗
  • 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. PubMed 18226685 ↗
  • 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. PubMed 17478348 ↗
  • 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. PubMed 27080611 ↗
  • 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. PubMed 17427065 ↗
  • 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. PubMed 25792387 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03250286
Lead sponsor
Woo Hyun Paik
Responsible party
Woo Hyun Paik (Professor, Seoul National University Hospital) — Sponsor-investigator
First posted
Aug 15, 2017
Start date
Jul 25, 2017
Primary completion
Jun 5, 2020
Completion
Jun 5, 2020
Last update
Mar 18, 2021

Study contacts

Woo Hyun Paik, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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