The effectiveness and safety of a new needle in endoscopic ultrasound-guided tissue sampling for pancreatic solid lesions

A prospective, multi-center, comparative, open-label study to evaluate the effectiveness and safety of a new needle in endoscopic ultrasound-guided tissue sampling for pancreatic solid lesions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003877

Enrollment

108

Registered

2019-05-02

Start date

2019-06-07

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Comparision of specimen adequacy and diagnostic accuracy between a needle and a conventional needle in endoscopic ultrasound-guided tissue sampling for pancreatic solid lesions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Adults over 19 years ? Pancreastic solid lesions confirmted by image studies ? Lesions accessible by endoscopic-ultrasound image ? Patients who are willing to participate in clinical trials, follow procedures, and visit the hospital for follow-up ? Patients who voluntarily signed a written consent form by listening to the purpose, method, and effect of this trial

Exclusion criteria

Exclusion criteria: ? Pregnant or fertility women who can not use appropriate contraception ? Patients who could not undergo the endoscopic procedure ? Patients with hemorrhagic disease or coagulopathy ? Platelet count less than 60,000 / mm3 or exceeds or International Normalized Ratio (INR) > 1.5 ? Patients with unstable heart disease or myocardial infraction within 6 months of participating in clinical trial ? Patients with psychiatric illness or condition (eg dementia, seizure) ? Patients who participated in clinical trials of other medicines or medical devices within the past 3 months. ? Others which is impossible to participate the clinical trial by the judge of clinicians

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy	—

Secondary

Measure	Time frame
Specimen adequacy	—

Countries

Korea, Republic of

Contacts

Public ContactCHANGMIN CHO

Kyungpook National University Medical Center

changmincho@gmail.com+82-53-200-2608

Outcome results