Role of EUS in High Risk of Choledocholithiasis

NCT03250286 | Completed

• 1 other identifier: 1705-070-854
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Choledocholithiasis

Outcome Measures

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

  6 months after randomization

Secondary Outcomes (1)

• Length of hospital stay

  6 months after randomization

Other Outcomes (1)

• The rate of diagnostic ERC (Endoscopic retrograde cholangiography)

  6 months after randomization

Study Arms (2)

EUS-ERCP group

EXPERIMENTAL

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

ERCP group

ACTIVE COMPARATOR

ERCP without EUS is performed in all patients.

Device: ERCP

Interventions

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.

EUS-ERCP group

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.

ERCP group; EUS-ERCP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Woo Hyun Paik: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (7)

• 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.

  PMID: 20105473 BACKGROUND

• 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.

  PMID: 28174126 BACKGROUND

• 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.

  PMID: 18226685 BACKGROUND

• 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.

  PMID: 17478348 BACKGROUND

• 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.

  PMID: 27080611 BACKGROUND

• 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.

  PMID: 17427065 BACKGROUND

• 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.

  PMID: 25792387 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Woo Hyun Paik, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 15, 2017
• Study Start: July 25, 2017
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

KR (1)