Not Yet RecruitingNot Applicable

22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions

China576 participantsStarted 2025-07

Plain-language summary

The investigators conduct a prospective, multicenter, blinded, randomized controlled trial to compare the diagnostic value and safety of the 22G Adapt needle versus the 22G Franseen needle for histopathological evaluation of solid lesions.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Over 18 years old and under 85 years old; * Presence of a solid lesion greater than 1 cm in diameter, as identified by cross-sectional imaging (Magnetic Resonance Imaging, Computed Tomography or abdominal ultrasound), located in anatomical regions accessible via endoscopic ultrasound (EUS)-including but not limited to the pancreas, retroperitoneum, liver, mediastinum, or subepithelial layers of the gastrointestinal tract-where tissue acquisition is clinically indicated to establish a definitive histopathological diagnosis.; * Must be able to receive examinations in the research center; * Must be able to sign the informed consent. Exclusion Criteria: * Hemoglobin ≤8.0 g/dL; * Pregnant women; * Coagulation disorders(Platelet \<50,000/mm3, International Normalized Ratio \> 1.5); * Took anticoagulants such as aspirin, warfarin in the latest week; * Acute pancreatitis in the past two weeks; * inability to safely perform Endoscopic Ultrasound-Guided Tissue Acquisition (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The histological diagnostic yields

Timeframe: up to 15 months

Trial details

NCT IDNCT07012694

SponsorHuazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Bin Cheng

+8613986097542 b.cheng@tjh.tjmu.edu.cn

View on ClinicalTrials.gov More Pancreatic Neoplasms trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.