Clinical trial · Interventional
Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Cystic, Mucinous, and Serous | Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethanol | Drug | — | UNRESOLVED |
| Lidocaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pancreatic Cyst Ethanol Injection
- 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.
- interventionNames
- Drug: Ethanol
- Drug: Lidocaine
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 1 year after final treatment
- description
- Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDGomez V, Takahashi N, Levy MJ, McGee KP, Jones A, Huang Y, Chari ST, Clain JE, Gleeson FC, Pearson RK, Petersen BT, Rajan E, Vege SS, Topazian MD. EUS-guided ethanol lavage does not reliably ablate pancreatic cystic neoplasms (with video). Gastrointest Endosc. 2016 May;83(5):914-20. doi: 10.1016/j.gie.2015.08.069. Epub 2015 Sep 9. PMID 26363331