Exploratory Study on EUS-guided Portal Vein CTCs and Their Subtypes Combined With Multi-omics Detection for Early Warning of Pancreatic Cancer Recurrence and Metastasis

A total of 20 participants are stratified based on imaging studies into the resectable pancreatic cancer group (8 cases), the borderline resectable pancreatic cancer group (8 cases), and the locally advanced pancreatic cancer group (4 cases). These patients have solid space-occupying lesions (with a diameter >1cm) within the accessible range of endoscopic ultrasound (EUS) for the pancreas as indicated by imaging studies. Every trial patient will get a unique identification 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; 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 sampling procedures for all of them in a strict sequence: first, under EUS guidance, 10ml of portal vein blood is prioritized for collection using a 22G ECHO 3-22 needle to avoid contamination. Subsequently, the investigators will do the needle passes for 3 times on the pancreatic lesion with 5 mL wet suction for tissue acquisition. Finally, 10ml of peripheral blood is collected. Samples are processed using CTC100 system or IFC-IMP technology, followed by scRNA-seq (10xGenomics) and proteomic analysis (timstofPro2/orbitrap). The results will be fed back to clinicians within 3 working days. Without knowing the sample source (blinded to specific subtypes initially), the cytologist and pathologist evaluate the specimen quality and make diagnosis.

Follow up (outpatient follow up or telephone follow up) the patients at 1 week, 12 weeks and 36 weeks after the puncture 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.