Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Condition: Neoplasms, Cystic, Mucinous, and Serous
MeSH terms: Neoplasms; Neoplasms, Cystic, Mucinous, and Serous
Intervention: Ethanol; Lidocaine
Intervention description: EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.; The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.
Intervention MeSH terms: Ethanol; Lidocaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intraductal Papillary Mucinous Neoplasm; Mucinous Cystic Neoplasm; Endoscopic Ultrasound; Ethanol

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presence of a pancreatic cystic lesion, > 1 cm in maximum diameter

          2. Treatment of the cystic lesion is desired due to symptoms or concern for subsequent
             malignancy

          3. Age > or = 18 years

          4. Able to give informed consent

          5. Surgical treatment has been considered, and a surgical consultation offered to the
             patient, but:

               1. Subject's cyst does not meet consensus criteria for surgical resection, or

               2. Subject is deemed a poor operative candidate, or

               3. Ethanol ablation would allow a subtotal rather than total pancreatectomy, or

               4. Subject has decided not to undergo surgical treatment.

        Exclusion Criteria:

          1. Known or suspected pregnancy, or nursing

          2. History of pancreatitis within past 3 months

          3. Main pancreatic duct is dilated to > 4mm in neck, body, or tail

          4. Cyst is known to communicate with the pancreatic duct

          5. Cyst has a primarily microcystic architecture on EUS

          6. Cyst is immediately adjacent to the main pancreatic duct on EUS

          7. Cyst has a connection to the main pancreatic duct seen during EUS

          8. During initial cyst aspiration, more fluid is recovered than expected (suggesting
             communication to the main pancreatic duct)

          9. Pancreatic cytology has demonstrated cancer