Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Cystadenocarcinoma

Cystadenoma

Cystadenoma, Mucinous

Cystadenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Adenocarcinoma of the Appendix

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Paclitaxel

Albumin-Bound Paclitaxel

Ethanol

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tubulin Modulators

Antimitotic Agents

Anti-Infective Agents, Local

All patients will receive at least one treatment with alcohol and paclitaxel.

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.

Ethanol and Paclitaxel Injection

Brian M Yan, MD, FRCPC

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.

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

EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Proportion of patients without cysts at 6 months

Degree of cyst epithelial ablation in those undergoing resection

Change of CEA level in those with persistent/recurrent cyst

Proportion of patients without cysts at 12 months

Proportion of patients without cysts at 18 months

Proportion of patients with no cysts at 24 months

University of Western Ontario, Canada

Lawson Health Research Institute

Assistant Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm	NCT01525706	Mucinous Cystic... Mucinous Cystad... Mucinous Cystad... Benign Neoplasm...	Ethanol and Pac...	18 Years - 85 Years	Lawson Health Research Institute
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm	NCT01525706	Mucinous Cystic... Mucinous Cystad... Mucinous Cystad... Benign Neoplasm...	Ethanol and Pac...	18 Years - 85 Years	Lawson Health Research Institute

Spots Global Cancer Trial Database for mucinous cystadenoma of pancreas