Prospective randomized trial comparing the efficient core tissue acquired from a core biopsy needle and a conventional needle in solid mass lesions

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001566

Enrollment

Registered

2015-07-13

Start date

2013-05-11

Completion date

Unknown

Last updated

2019-03-11

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, Procedure/Surgery : EUS-FNA group: tissue sampling was performed with a 22-gauge conventional needle (Echotip

Wilson-Cook Medical, Winston-Salem, North Carolina, USA). If the initial three passes failed to retrieve an adequate specimen, patients were crossed over to undergo up to three passes with the alterna

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: solid mass lesions within the wall of or adjacent to gastrointestinal tract those were revealed by CT or MRI

Exclusion criteria

Exclusion criteria: mass lesion was not seen at endoscopic ultrasound mass with a cystic component of over 25% coagulopathy (international normalized ratio of prothrombin time (PT INR) > 1.5 or platelet count < 80,000/mm3)

Design outcomes

Primary

Measure	Time frame
The area of efficient core tissue	—

Secondary

Measure	Time frame
median number of passes required to obtain core specimen;diagnostic accuracy;complication rates	—

Countries

Korea, Republic of

Contacts

Public ContactBan Seok Lee

Kyungpook National University Medical Center

Outcome results