Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions

Launched by CHANGHAI HOSPITAL · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for taking samples from solid pancreatic lesions, which are abnormal growths in the pancreas that may need to be tested for diseases like cancer. The researchers want to see if using a technique called macroscopic on-site evaluation (MOSE) is as accurate as taking two separate needle samples with an endoscopic ultrasound procedure. Participants who have a pancreatic mass larger than 1 cm and need a tissue diagnosis may be eligible to join the study.

If you participate, you will undergo a procedure where a thin needle is used to collect tissue from the lesion. Depending on the method being tested, the way your tissue samples are collected may differ. This trial aims to compare how effective each approach is in obtaining the right amount of tissue for diagnosis, as well as how many needle punctures are needed and how long the procedure takes. It's important to know that the trial is not yet recruiting participants, and certain health conditions may prevent someone from joining, such as severe heart or bleeding disorders. If you're interested or have questions, please talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
• • 1. 18-80 years old (inclusive), male and female;
• • 2. patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
• • 3. written informed consent was obtained;
• Exclusion Criteria:
• • (Before the trial, participants could not be enrolled if they met any of the following requirements)
• • 1. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
• • 2. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
• • 3. confirmed pregnancy or possible pregnancy;
• • 4. pathological diagnosis has been obtained by other methods;
• • 5. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
• • 6. other situations where EUS-FNB could not be performed.