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Completed

NCT Number: NCT02158039

Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

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.

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Key information

Conditions

Neoplasms, Cystic, Mucinous, and Serous Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of a pancreatic cystic lesion, > 1 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:
  • Subject's cyst does not meet consensus criteria for surgical resection, or
  • Subject is deemed a poor operative candidate, or
  • Ethanol ablation would allow a subtotal rather than total pancreatectomy, or
  • 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 neck, 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

Treatment and study plan

Ethanol

Drug

EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.

Lidocaine

Drug

The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.

Primary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2014
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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