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CholedocholithiasisNCT03250286

Role of EUS in High Risk of Choledocholithiasis

A study testing EUS and ERCP in people with Choledocholithiasis, run by Woo Hyun Paik at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Choledocholithiasis
What is being tested?
EUS and ERCP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSouth Korea
Study dates
25 Jul 2017to 5 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

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.

Being tested
EUS, ERCP
Medical subject headings
Choledocholithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUSDevice

    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.

  • ERCPDevice

    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.
Study groups in NCT03250286
Study groupRoleWhat they receive
EUS-ERCP groupExperimentalEUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.
Receives: Device: EUS; Device: ERCP
ERCP groupActive comparatorERCP without EUS is performed in all patients.
Receives: Device: ERCP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months after randomization

Secondary outcomes (1)

  1. Length of hospital stay

    Length of hospital stay

    Measured: 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start25 Jul 2017
  3. Primary completion5 Jun 2020
  4. Study completion5 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03250286
Sponsor's protocol ID
1705-070-854
Status last verified
Mar 2021
First submitted
18 Jul 2017
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing EUS and ERCP in people with Choledocholithiasis, run by Woo Hyun Paik at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03250286, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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