Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2018 |
| Start Date: | June 2004 |
| End Date: | September 2015 |
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.
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.
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ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5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.
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ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5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.
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
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