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

Launched by HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jun 7, 2025

Keywords

ClinConnect Summary

This clinical trial is researching two different types of needles used to take tissue samples from solid lesions, which are abnormal growths that can occur in areas like the pancreas and liver. The goal is to find out which needle, the 22G Adapt or the 22G Franseen, is better at providing accurate results while also being safe for patients. This study will include adults between the ages of 18 and 85 who have a solid lesion larger than 1 cm that needs to be examined to determine if it is cancerous or not.

If you or a loved one are considering participating in this trial, you should know that you must be able to safely undergo a procedure called endoscopic ultrasound (EUS), where a small camera is inserted into your body to help locate the lesion. Participants will need to sign consent forms and be able to attend appointments at the research center. However, people with certain health issues, like low blood counts, blood clotting disorders, or recent pancreatitis, will not be eligible. Overall, this trial aims to improve how doctors can diagnose serious conditions through safe and effective methods.

Gender

ALL

Eligibility criteria

• 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.