Randomized trial in EUS-FNB for solid pancreatic lesions

JRCT ID: jRCT1042220099

Registered date:25/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Solid pancreatic lesions not less than 10 mm
• Date of first enrollment: 13/02/2023
• Target sample size: 192
• Study type: Interventional

Intervention(s)

Subjects will be randomly assigned to a conventional needle group or a new needle group for the needle used during EUS-FNB.
Conventional needle group: 22G Franseen needle (Acquire TM) will be used. New needle group: 22G Trident needle (Trident TM) or 3-Point needle (TopGain TM) will be used. Since it is expected that some facilities will have difficulty employing both needles, one of the needles will be used in the new needle group, and in facilities where both needles can be used, they will be used alternatively.

Outcome(s)

• Primary Outcome: Histological tissue collection rate

Secondary Outcome

Histological tissue collection rate among new needles
Histological diagnostic ability
Puncture success rate at first shot
Evaluation of the easiness of the puncture
Adverse events
Comparison of core tissue length and area

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients with solid pancreatic lesions not less than 10 mm on CT or MRI which require histological diagnosis by EUS-FNB.
(2)Patients over 20 years old at the time of enrollment.
(3)Preservation of bone marrow function at the time of diagnosis.
(4)Patients in which antithrombotic drugs are not used within one week or can be withdrawn or replaced.
(5)Provision of written consent to participate in the study.

Exclude criteria

(1)Uncontrollable infection including active tuberculosis
(2)Serious adverse events
(3)Severe mental disorder
(4)Judgement as being ineligible by the principal or subinvestigator.

Related Information

• Primary Sponsor: Ishikawa Takuya