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
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|
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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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)
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Mark Topazian, MD||Mayo Clinic|