Comparison of between techniques for EUS-guided tissue acquisition

A prospective, randomized trial comparing novel torque technique and fanning technique for EUS-guided tissue acquisition in solid pancreatic lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004678

Enrollment

155

Registered

2020-01-30

Start date

2020-02-21

Completion date

Unknown

Last updated

2022-11-28

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

Conditions

None listed

Interventions

Procedure/Surgery : Interventions All patients who will meet the inclusion criteria will undergo EUS-FNB with 22-gauge Acquire® FNB needle (Boston Scientific Co., Natick, MA, USA) in random sequence

the number of needle passes had previously been decided upon and is not subject to change. In other words, the randomization will be performed using the block method by a computer-generated random num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Consecutive patients who will be referred to each medical center for EUS-FNB to evaluate pancreatic solid masses 2. Age of 19 or more years old 3. Able to voluntarily agree to participate and to sign informed consent 4. Willingness to participate and sign the informed consent agreement.

Exclusion criteria

Exclusion criteria: 1) if the mass had only a cystic component without a solid component suspected with malignant transformation 2) if the coagulation parameters were abnormal (international normalized ratio >1.5 or platelet count <50,000 cells/cmm 3) postponing the antithrombotic therapy was impossible 4) if the patient had cardiopulmonary instability 5) pregnancy

Design outcomes

Primary

Measure	Time frame
the proportion of achievement of true diagnosis without ROSE on the first pass	—

Secondary

Measure	Time frame
the procurement rate of optimal histologic cores (possible for IHC stain);Diagnostic yield: sensitivity, specificity, positive predict value, negative predict value;Rate of technical failure;Procedure/Device related major adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

mdsewoopark@gmail.com+82-31-8086-2858

Outcome results