22G-Adapt Needle Biopsy Versus Fine-needle Aspiration in Endoscopic Ultrasound-guided Sampling of Solid Lesions

Launched by HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Aug 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of needle called the 22G Adapt Aspiration needle to see how well it works for taking tissue samples from solid lumps or masses in the body, particularly in areas like the pancreas, liver, and lungs. The researchers want to find out if this new needle is safe and effective compared to a standard method known as fine-needle aspiration. The study will involve multiple centers, and it aims to help doctors better diagnose conditions like pancreatic or abdominal tumors.

To participate in this trial, individuals need to be between 18 and 85 years old and have solid masses that are larger than 1 cm, as confirmed by imaging tests like MRI or CT scans. They should also be able to come to the research center for tests and provide informed consent. However, those with certain health issues, such as low blood counts, pregnancy, or recent acute pancreatitis, will not be eligible to join. Participants can expect to undergo procedures to collect tissue samples, which will help doctors understand more about their condition. This trial is not yet recruiting, so there will be more information available once it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Over 18 years old and under 85 years old;
• • Imaging examinations (MRI, CT, B-ultrasound) reveal the presence of solid masses (with a diameter \> 1 cm) within the regions accessible by endoscopic ultrasound in the pancreas, peripancreatic area, liver, adrenal gland, kidney, mediastinum, lung, and gastrointestinal submucosa. Biopsy is necessary for the diagnosis of these lesions;
• • 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 (PLT \<50,000/mm3,INR \> 1.5);
• • Took anticoagulants such as aspirin, warfarin in the latest week;
• • Acute pancreatitis in the past two weeks;
• • inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); refusal or inability to provide an informed consent.