A multicenter randomized prospective study of heparin wet-suction versus conventional suction for EUS-FNB of solid pancreatic mass

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Drug : 1. Heparin wet suction technique (HWST) Prepare the 22G needle in the following order before connecting it to the endoscopic channel. Remove the stylelet first, as shown in the picture below, and inject 2ml of 5000 Uheparin to coat the needle with heparin. Then connect the 20‐ml suction ring. A typical linear endoscopic ultrasound device is used to find a solid pancreatic mass.After inserting a needle into the lesion by avoiding the surrounding blood vessels, apply negative pressure with a 20‐ml syringe to collect tissue by repeating 10‐15 back and forth movements. 2. Conventional suction technique (CST) A typical linear endoscopic ultrasound device is used to find a pancreatic solid mass. Insert a needle into the lesion avoiding the surrounding blood vessels. Apply the negative pressure with a 20‐ml syringe and collect the tissue by repeating 10‐15 back and forth movements. 3. Heparin wet suction technique group Collect tissue twice in the order of HWST/CST. 4. CST technique group Collect tissue twice in the order of CST/HWST. 5. Tissue Processing After performing HWST and CST, respectively, discharge the tissue obtained on the slide by inserting a stylelet. Fi Xthe obtained tissue in a formalin solution. The pathologist does not know how the sample was collected, so that the result can be determined. This method is the same as proceeding under daily treatment. CONDITION: Neoplasms PRIMARY OUTCOME: Diagnostic yield : Defined as the percentage of lesions sampled in which a tissue diagnosis was obtained. SECONDARY OUTCOME: Available immunohistochemical staining Occurrence of adverse events Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (‐LR), and accuracy Technical success INCLUSION CRITERIA: 1. Men and women aged 20 or older who voluntarily obtained consent (In the case of elderly subjects, read and sign the signed consent form after fully explaining the research content verbally before reading the written consent form, and if possible, listen to the explanation together.) 2. Patients who agree to the clinical trial 3. Pancreatic solid mass 4. Size of lesion: =1 cm in long diameter
Epistemonikos ID: cfab4b41bff74056b60892596882daf7f0ff4bd0
First added on: Feb 20, 2024