Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies

Launched by UNIVERSITY OF COLORADO, DENVER · May 21, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to evaluate pancreatic cystic lesions (PCLs), which are fluid-filled sacs in the pancreas that can sometimes be found during imaging tests like CT or MRI scans. The study is comparing two methods of collecting samples from these cysts using a procedure called endoscopic ultrasound (EUS). One method is the traditional fine needle aspiration (EUS-FNA), which collects fluid from the cyst, while the other method includes a newer technique using micro forceps that can take a small piece of the cyst wall for further examination. The goal is to see if the newer method can provide better information about the cysts, helping doctors determine if they are potentially harmful.

To participate in this trial, you would need to be an adult over 18 years old with a pancreatic cyst that is larger than 20 millimeters and appropriate for sampling. The study is open to all genders, but certain conditions, like bleeding disorders or being pregnant, would make you ineligible. If you join the trial, you can expect to undergo the EUS procedure, where your doctor will collect samples to help clarify the nature of the cyst. This research could improve how doctors diagnose and manage pancreatic cysts, potentially changing treatment approaches in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients \>18 years old
• • Cysts \> 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis
• Exclusion Criteria:
• • Age \<18 years
• • Inability to provide informed consent
• • Thrombocytopenia (Platelets \< 50,000) or coagulopathy (INR \> 1.8)
• • Pregnancy
• • Post-surgical anatomy where the cyst is not accessible for FNA
• • EUS findings suggesting that cyst FNA would be unsafe (e.g. intervening blood vessels)
• • EUS appearance suggesting FNA is not indicated (e.g. cyst smaller than prior radiologic imaging, cyst not seen, EUS suggestive of serous cystadenoma)