Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Overview

About this study

Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts will undergo endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This is a pilot study to assess safety and efficacy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Presence of a pancreatic cystic lesion, > 1.5 cm in maximum diameter
  • Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
  • Age > or = 18 years
  • Able to give informed consent
  • Surgical treatment has been considered, and a surgical consultation offered to the patient, but the subject's cyst does not meet consensus criteria for surgical resection, or the subject is deemed a poor operative candidate, or ethanol ablation would allow a subtotal rather than total pancreatectomy, or the subject has decided not to undergo surgical treatment.

Exclusion Criteria:

  • Known or suspected pregnancy, or nursing
  • History of pancreatitis within past 3 months
  • Main pancreatic duct is dilated to > 4mm in body or tail
  • Cyst is known to communicate with the pancreatic duct
  • Cyst has a primarily microcystic architecture on EUS
  • Cyst is immediately adjacent to the main pancreatic duct on EUS
  • Cyst has a connection to the main pancreatic duct seen during EUS
  • During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct)
  • Pancreatic cytology has demonstrated cancer

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Topazian, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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CLS-20118287

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