Multicentered Prospective Randomized Controlled Trial For Solid Pancreatic Lesions
Pancreas Neoplasm
About this trial
This is an interventional treatment trial for Pancreas Neoplasm focused on measuring Contrast-Enhanced EUS, FNB, Solid Pancreatic Lesions
Eligibility Criteria
Inclusion Criteria:
- referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter.
Exclusion Criteria:
- with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy
- who cannot provide informed consent.
Sites / Locations
- Department of Surgery; The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Contrast-enhanced EUS (CH-EUS) Arm
Conventional EUS Arm
After initial evaluation, 2.5ml of second-generation contrast media, SonoVue (Bracco, Ceriano Laghetto, Italy), will be injected. After infusion, the point of puncture will be determined when the parenchyma of the pancreas was enhanced. The contrast-enhanced area was identified and then the biopsy was directed toward that area, while avoiding unenhanced (i.e. necrotic) areas and not changing the target lesion. Rest of the procedure is identical with that in conventional EUS arm.
Patients will undergo EUS FNB with the 22-gauge FNB needle (Acquire®, Boston Scientific Natick, MA). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed