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

Phase 1TerminatedNCT01525706

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mucinous Cystic Tumor With Moderate Dysplasia Mucinous Cystadenoma of Pancreas Mucinous Cystadenocarcinoma of Pancreas

Interventions

Ethanol and Paclitaxel InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Efficacy: Cyst Resolution

Proportion of patients without cysts at 6 months

Time frame: 6 months

Efficacy: Degree of Ablation

Degree of cyst epithelial ablation in those undergoing resection

Time frame: 6 months

Secondary Outcomes

Safety

Safety of ethanol/paclitaxel ablation

Time frame: 30 day

Efficacy: Change of tumor markers

Change of CEA level in those with persistent/recurrent cyst

Time frame: 12 month

Efficacy: Cyst Resolution

Proportion of patients without cysts at 12 months

Time frame: 12 month

Efficacy: Cyst Resolution

Proportion of patients without cysts at 18 months

Time frame: 18 months

Efficacy: Cyst Resolution

Proportion of patients with no cysts at 24 months

Time frame: 24 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes