Clinical trial · Interventional
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitment
Summary
Brief summary (as posted)
Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection. Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm of Pancreas | Benign Pancreatic Neoplasm | ALIAS | 0.90 |
| Mucinous Cystadenocarcinoma of Pancreas | — | UNRESOLVED | — |
| Mucinous Cystadenoma of Pancreas | — | UNRESOLVED | — |
| Mucinous Cystic Tumor With Moderate Dysplasia | Pancreatic Mucinous Cystic Neoplasm with Intermediate Grade Dysplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethanol and Paclitaxel Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ethanol and Paclitaxel Injection
- description
- All patients will receive at least one treatment with alcohol and paclitaxel.
- interventionNames
- Drug: Ethanol and Paclitaxel Injection
Primary outcomes (2)
- measure
- Efficacy: Cyst Resolution
- timeFrame
- 6 months
- description
- Proportion of patients without cysts at 6 months
- measure
- Efficacy: Degree of Ablation
- timeFrame
- 6 months
- description
- Degree of cyst epithelial ablation in those undergoing resection
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Mucinous cystic neoplasm defined by cyst fluid analysis \[23, 28\]: * CEA \> 192ng/mL * Amylase \< 800 IU/L * Cytology negative for malignant cells * No communication of cyst with pancreatic duct on 2 imaging studies (EUS, CT, MRCP, or ERCP) 2. Cyst size \> 15mm but \<50mm 3. 3 or fewer cyst compartments 4. Age ≥18 and ≤ 85 Exclusion Criteria: 1. Inability to safely undergo EUS examination with standard conscious sedation 2. Inability for safe FNA needle insertion into the cyst (eg: intervening vessel) 3. Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia) 4. Coagulopathy (INR\>1.5 or platelets\<50) 5. Active pancreatitis or pancreatic infection 6. Active sepsis/bacteremia 7. Inability to provide informed consent 8. Pregnancy 9. Breastfeeding women
References
Publications (4)
- RESULTOh HC, Seo DW, Song TJ, Moon SH, Park DH, Soo Lee S, Lee SK, Kim MH, Kim J. Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection treats patients with pancreatic cysts. Gastroenterology. 2011 Jan;140(1):172-9. doi: 10.1053/j.gastro.2010.10.001. Epub 2010 Oct 13. PMID 20950614
- RESULTOh HC, Seo DW, Lee TY, Kim JY, Lee SS, Lee SK, Kim MH. New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008 Apr;67(4):636-42. doi: 10.1016/j.gie.2007.09.038. Epub 2008 Feb 11. PMID 18262182
- RESULTDeWitt J, DiMaio CJ, Brugge WR. Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. Gastrointest Endosc. 2010 Oct;72(4):862-6. doi: 10.1016/j.gie.2010.02.039. PMID 20883866
- RESULTDeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4. PMID 19577745