A Prospective, Multicenter, Blinded, Randomized Controlled Trial Assessing the Diagnostic Yield and Tissue Adequacy of 22G Adapt Versus 22G Franseen Fine-Needle Biopsy for Solid Lesions Under Endoscopic Ultrasound Guidance

Participants are randomized into two groups: the EUS-FNB-A group (22G Franseen needle) and the EUS-FNB-B group (22G Adapt needle). The primary endpoint is diagnostic accuracy for solid mass lesions. A non-inferiority design is adopted, with group A as the control. The significance level (α) is set at 0.025 (one-sided), with a type II error (β) of 0.15, providing a statistical power of 85%. Based on previous literature, the assumed diagnostic accuracy of the 22G Adapt FNB is 90%, compared to 92% for the 22G Franseen FNB, with a non-inferiority margin of -10%. Assuming a 1:1 allocation and accounting for a 20% dropout rate, 288 participants are planned for each group, totaling 576 participants.

Done by professional statistical people with randomized block grouping method and SAS 9.4 statistical software to generate randomized serial number（001-576）for the two groups in 1:1 manner. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 4, totally 144 randomized block. The randomized grouping will be generated in duplicate copies and sealed. One copy send to trial centers for patient allocating, and the another copy be saved by the trial applicant unit. Every trail centers will be responsible for the screening of qualified patients, rank them in visit time to get the randomized grouping number so as to determine them goes to the EUS-FNA or EUS-FNB.The research people and patients in all trial centers should not know the the randomized grouping number and relevant groups. The group name will be sealed under scratch card. Every trial patients will get a unique randomized number, and it will not change through out the whole trial.

Use the inclusion and exclusion criteria to observe the patients and do relative inspections, and confirm if the patients qualified or not to the trial. Record the result of last time test before the treatment. Although it is better to get the informed consent before doing all kinds of observation and tests, if for some reason, the medical imaging examination has completed, as long as the imaging examination was done within 3 weeks before the needle biopsy, it can still be collect as baseline data (imaging examination can be done at other hospitals, but the trial center should issue a new evaluation report 1 week before the patient join the trial group); other lab test items done at 2 weeks before the needle biopsy can still be collect as baseline data for pre-research use, but these tests should be done at the trail center hospital so as to guarantee the data trace ability.

The investigators will do the needle passes for 2 times for all of them:the 1 needle passes with Slow-Pull and the 2 needle passes with 5 mL wet suction. If no core tissues obtained or the operator/onsite pathologist determine insufficient specimen after the operations above, then remedy procedures will be done, the operator use proper puncture method to continue the remedy biopsy. After the first round of needle biopsy, if the trial patient cannot be diagnosed, by getting the agreement of the patient, the patient will be cross-over to another trial group and do needle biopsy again on the same lesion 1 week later with the method mentioned above. Without knowing the needle biopsy type, the cytologist and pathologist evaluate the specimen quality and make diagnosis. Every specimen will be independently evaluated and diagnosed by 2 experts. If the 2 experts have different judgments, then these two experts discuss together and make the final diagnose discussion. If the same sample has 2 or more cytology smear slides, than take the highest score slide as the result. Follow up (outpatient follow up or telephone follow up) the patients at 1 week, 12 weeks and 36 weeks after the needle biopsy and collect the patients clinical data and confirm their final diagnosis.

During the trial, if severe adverse event occurs, the trialed center must take immediate actions necessary to guarantee the trialed patients' safety. Once severe adverse event occurs, the researchers should inform the trial applicant and the trail center's ethics committee within 24 hours after the researchers gets to know the adverse event. And the researchers should also fax the report to State Food and Drug Administration of China and the local provincial food and drug administration. After receiving the report, the applicant should inform other clinical trial centers within 24 hours. All the severe adverse events should be filed at group leader medical center and other trial centers.