CompletedNot Applicable

EUS-guided Ablation of Pancreatic Cyst Neoplasms

United States1,000 participantsStarted 2016-06-01

Plain-language summary

This is a registry that will maintain prospective data on the clinical outcomes of all patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Benign branch-duct intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst neoplasm (MCN) measuring \>2 and up to 4cm in size and located in the head or body of the pancreas.
✓. Benign branch-duct IPMN or MCN measuring \> 2 and up to 4cm in size and located in the tail of the pancreas in a high-risk surgical candidate.
✓. A branch-duct IPMN or MCN with high-risk features (mural nodule or enlarging in size) in a high-risk surgical patient.
✓. Indeterminate cyst lesions

Exclusion criteria

✕. Cysts measuring \<2cm or \>4cm.
✕. Multiloculated cysts (\>4 locules).
✕. Cysts with vascular supply.
✕. Cysts communicating with the main pancreatic duct via an obvious side-branch measuring 2mm or more in diameter.
✕. Cysts with hypoechoic mass lesions that on fine needle aspiration (FNA)reveal malignant cells.
✕. Recent history of pancreatitis and EUS findings suggestive of a pseudocyst.
✕. Bleeding tendency; international normalized ratio (INR) \>1.4 or platelet count \<70,000.

What they're measuring

This study will evaluate the clinical outcomes (effectiveness) of all patients with pancreatic cyst lesions undergoing EUS-guided ethanol ablation. This will include complete resolution of the pancreatic cyst lesion at the end of the treatment period.

Timeframe: Up to 12 months

Trial details

NCT IDNCT02422147

SponsorAdventHealth

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-12

View on ClinicalTrials.gov More Pancreatic Cyst trials