NCT01525706

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

EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2012-02-03
• Last updated: 2016-11-02

Locations

1 site across 1 country: Canada