Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution. After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [1 year after final treatment]. Number, participants. Number of participants with adverse events: Pancreatic Cyst Ethanol Injection (n=23): 7. Number of participants without adverse events: Pancreatic Cyst Ethanol Injection (n=23): 16.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Subjects With Complete or Partial Ablation of the Treated Cyst [1 year after final treatment]. Number, participants. Complete ablation of treated cyst: Pancreatic Cyst Ethanol Injection (n=23): 2. Greater than or equal to 80% cyst volume reduction: Pancreatic Cyst Ethanol Injection (n=23): 10. Less than 80% cyst volume reduction: Pancreatic Cyst Ethanol Injection (n=23): 10. Cyst volume increase: Pancreatic Cyst Ethanol Injection (n=23): 1.