Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
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.
|Mucinous Cystic Tumor With Moderate Dysplasia Mucinous Cystadenoma of Pancreas Mucinous Cystadenocarcinoma of Pancreas Benign Neoplasm of Pancreas||Drug: Ethanol and Paclitaxel Injection||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm|
- Efficacy: Cyst Resolution [ Time Frame: 6 months ]Proportion of patients without cysts at 6 months
- Efficacy: Degree of Ablation [ Time Frame: 6 months ]Degree of cyst epithelial ablation in those undergoing resection
- Safety [ Time Frame: 30 day ]Safety of ethanol/paclitaxel ablation
- Efficacy: Change of tumor markers [ Time Frame: 12 month ]Change of CEA level in those with persistent/recurrent cyst
- Efficacy: Cyst Resolution [ Time Frame: 12 month ]Proportion of patients without cysts at 12 months
- Efficacy: Cyst Resolution [ Time Frame: 18 months ]Proportion of patients without cysts at 18 months
- Efficacy: Cyst Resolution [ Time Frame: 24 months ]Proportion of patients with no cysts at 24 months
|Study Start Date:||September 2012|
|Study Completion Date:||November 2016|
|Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Ethanol and Paclitaxel Injection
All patients will receive at least one treatment with alcohol and paclitaxel.
Drug: Ethanol and Paclitaxel Injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525706
|St. Joseph's Health Care|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Brian M Yan, MD, FRCPC||University of Western Ontario, Canada|