Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic… (NCT06994611) | Clinical Trial Compass
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Fine-needle Biopsy Combined With Macroscopic On-site Evaluation for Diagnosis of Solid Pancreatic Lesions
China148 participantsStarted 2025-06-25
Plain-language summary
The goal of this clinical trial is to compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time of macroscopic on-site evaluation (MOSE) and two punctures alone in Endoscopic ultrasound guided fine-needle biopsy (EUS-FNB) for solid pancreatic lesions. The main questions it aims to answer is: whether the diagnostic accuracy of EUS-FNB performed with two needle passes is not inferior to that of MOSE.
Participants with solid pancreatic lesions who needs histological diagnosis will receive EUS-FNB using 22G Franseen.
In Group 1, the macroscopically visible core (MVC) of the specimen was assessed. If the MVC of the sample obtained from the first needle was ≥10mm, the tissue strip was placed in Bottle A and fixed with formalin. A second needle was then used to obtain another tissue strip, which was directly placed into Bottle B containing formalin. However, if the MVC of the first needle sample was \< 10mm, the puncture procedure was continued until the cumulative length of sample's MVC was ≥10mm, and all the sample collected during this process were placed into Bottle A and fixed with formalin. In Group 2, two needles were used to obtain tissue strips, and all the tissue strips were placed into Bottle A formalin.
Researchers will compare the diagnostic efficacy, core tissue acquisition ability, number of punctures and puncture time between the MOSE technique and two-needle puncture method.
Who can participate
Age range
18 Years – 80 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
. 18-80 years old (inclusive), male and female;
. patients with pancreatic solid mass \> 1cm detected by CT/MRI/PET-CT or EUS and requiring EUS-FNB diagnosis.
. written informed consent was obtained;
Exclusion criteria
. contraindications to endoscopy, such as severe cardiovascular and cerebrovascular diseases;
. bleeding coagulation dysfunction (prothrombin international normalized ratio ≥1.5, platelet count ≤ 50 000) or use of antiplatelet drugs;
. confirmed pregnancy or possible pregnancy;
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.
. pathological diagnosis has been obtained by other methods;
. refuse to participate in the study, are participating in another observational clinical trial, or have participated in another clinical trial within 60 days.
. other situations where EUS-FNB could not be performed.