Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Neoplasms, Cystic, Mucinous, and Serous

Treatments: Drug: Ethanol; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02158039

498-04

Details and patient eligibility

About

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.

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 The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.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

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Pancreatic Cyst Ethanol Injection

Experimental group

Description:

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.

Treatment:

Drug: Ethanol

Drug: Lidocaine