Clinical Trial: Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Brief 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.


Detailed Summary:

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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.


Sponsor: Mayo Clinic

Current Primary Outcome:

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year after final treatment ]
    Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
  • Number of Subjects With Complete or Partial Ablation of the Treated Cyst [ Time Frame: 1 year after final treatment ]
    Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: September 30, 2013
Date Started: June 2004
Date Completion:
Last Updated: April 19, 2016
Last Verified: April 2016