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Clinical Trials/KCT0006185
KCT0006185
Not Yet Recruiting
N/A

Efficacy and safety of a novel device (OptimosTM Dilatation Device) in endoscopic retrograde cholangiopancreatography (ERCP) for removal of biliary stones: a pilot study

Chonnam National University Hospital0 sites20 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Chonnam National University Hospital
Enrollment
20
Status
Not Yet Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with all of the following:
  • 1\) Diagnosis of choledocholithiasis using abdominal imaging studies (e.g., CT, MRI, or endoscopic ultrasonography) or laboratory tests
  • 2\) Those who will follow the treatment methods and visit for follow\-ups
  • 3\) Those who understand and agree to participate in this study

Exclusion Criteria

  • Patients with any of the following:
  • 1\) Those who cannot give informed consent and agree to participate in this study
  • 2\) Those under the age of 20
  • 3\) Those over the age of 90
  • 4\) Those with previous history of bile duct stone removal by ERCP
  • 5\) Those with bleeding tendency/coagulopathy or platelet count \<50,000/mm3 or INR \>1\.5
  • 6\) Those taking antiplatelet agents (e.g.,clopidogrel, prasugrel, ticagrelor) and who have not stopped these medications for more than 5 days
  • 7\) Those taking anticoagulants (e.g., dabigatran, ribaroxaban, apixaban, edoxaban) and who have not stopped these medications for more than 48 hours
  • 8\) Those taking warfarin and who have not stopped this medication for more than 5 days or has INR \> 1\.5
  • 9\) Pregnant women

Outcomes

Primary Outcomes

Not specified

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