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Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

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ClinicalTrials.gov Identifier: NCT02158039
Recruitment Status : Completed
First Posted : June 6, 2014
Results First Posted : January 29, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Neoplasms, Cystic, Mucinous, and Serous Drug: Ethanol Drug: Lidocaine Phase 1

Detailed Description:

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Study Start Date : June 2004
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound
Drug Information available for: Lidocaine

Arm Intervention/treatment
Experimental: Pancreatic Cyst Ethanol Injection
EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
Drug: Ethanol
EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.

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




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158039


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark Topazian, MD Mayo Clinic

Publications:
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Responsible Party: Mark Topazian, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02158039     History of Changes
Other Study ID Numbers: 498-04
First Posted: June 6, 2014    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: February 5, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing can be arranged and will require IRB approval
Keywords provided by Mark Topazian, Mayo Clinic:
Intraductal Papillary Mucinous Neoplasm
Mucinous Cystic Neoplasm
Endoscopic Ultrasound
Ethanol
Additional relevant MeSH terms:
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Neoplasms, Cystic, Mucinous, and Serous
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ethanol
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents