Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Study Overview
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Brief Summary
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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.

Official Title
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EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Conditions
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Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas, Benign Neoplasm of Pancreas

Intervention / Treatment
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* Drug: Ethanol and Paclitaxel Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Cyst size > 15mm but <50mm 3 or fewer cyst compartments Age ≥18 and ≤ 85 Exclusion Criteria: Inability to safely undergo EUS examination with standard conscious sedation Inability for safe FNA needle insertion into the cyst (eg: intervening vessel) Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia) Coagulopathy (INR>1.5 or platelets<50) Active pancreatitis or pancreatic infection Active sepsis/bacteremia Inability to provide informed consent Pregnancy Breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethanol and Paclitaxel Injection<br>All patients will receive at least one treatment with alcohol and paclitaxel. | Drug: Ethanol and Paclitaxel Injection<br>* Endoscopic ultrasound will be used to locate and assess the pancreatic cyst. The fluid contents will be aspirated using a fine needle and sent for tumor marker analysis and cytology. With the needle maintained in the same position, 99% ethanol will be injected into the cyst. After 3-5 minutes of lavage, the entire volume of fluid will be removed from the cyst. The same volume of paclitaxel minus 1 mL [3mg/ml diluted in normal saline from original concentration of 6mg/mL] will be injected and left in the cyst. The needle is then retracted and the procedure completed. Patients will receive oral prophylactic antibiotics for 5 days after the procedure. Clinical follow up with MRI imaging with be done at 6, 12, 18, and 24 months. For those with a persistent cyst at 12 months, a repeat EUS FNI procedure will be done.<br>* Other names: Paclitaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Cyst Resolution | Proportion of patients without cysts at 6 months | 6 months | 
| Efficacy: Degree of Ablation | Degree of cyst epithelial ablation in those undergoing resection | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety of ethanol/paclitaxel ablation | 30 day | 
| Efficacy: Change of tumor markers | Change of CEA level in those with persistent/recurrent cyst | 12 month | 
| Efficacy: Cyst Resolution | Proportion of patients without cysts at 12 months | 12 month | 
| Efficacy: Cyst Resolution | Proportion of patients without cysts at 18 months | 18 months | 
| Efficacy: Cyst Resolution | Proportion of patients with no cysts at 24 months | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Ultrasound, Pancreatic Mucinous Cystic Neoplasm, Fine Needle Injection, Ethanol Ablation, Paclitaxel Ablation