Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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

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

Conditions
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Neoplasms, Cystic, Mucinous, and Serous

Intervention / Treatment
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* Drug: Ethanol
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pancreatic Cyst Ethanol Injection<br>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<br>* EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.<br>Drug: Lidocaine<br>* The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability | 1 year after final treatment | 
| Number of Subjects With Complete or Partial Ablation of the Treated Cyst | 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) | 1 year after final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm, Endoscopic Ultrasound, Ethanol