drugset / Trial / NCT02158039

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

NCT02158039

Phase 1 Completed 33 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

Summary

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 underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy. The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

Timeline

Start
2004-06
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Alcohol Other / unclassified 80 % Other
Subject Alcohol Other / unclassified 90 % Other
Background Lidocaine Other / unclassified 1 % Other