Utility of EUS-guided Microbiopsies in Pancreatic Cystic Lesions (NCT03578445) | Clinical Trial Compass
CompletedNot Applicable
Utility of EUS-guided Microbiopsies in Pancreatic Cystic Lesions
Denmark101 participantsStarted 2018-02-01
Plain-language summary
The purpose of this study is to determine clinical impact of EUS-guided microbiopsy procedure and supplementary molecular analyses compared to standard diagnostic workup of pancreatic cysts. The hypothesis is that a combination of previously mentioned modalities may change the management of some pancreatic cystic lesions, increase the diagnostic accuracy and optimize the discrimination between high- and low-risk pancreatic cysts.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients 18 years old or above
* Able to provide informed consent
* Pancreatic cyst with a diameter of 15 mm or above OR pancreatic cyst of any size with any one of either high-risk stigmata or worrisome features (obstructive jaundice in patients with a cyst in the head of the pancreas, solid component/mural nodule, thickened/enhancing cyst wall, main pancreatic duct ≥ 10 mm or abrupt change of main pancreatic duct diameter with distal atrophy)
Exclusion Criteria:
* Lactating and pregnant females
* Cystic lesions with a predominantly solid component, suspected of malignancy
* Patients with uncorrected coagulopathy (international normalized ratio \> 1.5 or platelet count \< 50 109/L)
* Patients with previous history of pancreatic cancer
* Patients with a history of major stomach surgery (e.g. Billroth 1 and 2, gastrectomy, gastric bypass, esophagectomy, resection of the liver or pancreas)
* Patients with disseminated malignant disease
* Patients unfit for surgery
* Patients where EUS-guided puncture of the lesion is not presumed technically feasible and/or safe
* Patients with systemic immunosuppressive disease or receiving systemic immunosuppressive treatment
* Patients with a history of recent pancreatitis (within 3 months)
What they're measuring
1
Clinical impact of EUS-guided microbiopsies in patients with pancreatic cystic lesions