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

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.

Full Title of Study: “EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Ethanol and Paclitaxel Injection
    • All patients will receive at least one treatment with alcohol and paclitaxel.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lawson Health Research Institute
  • Collaborator
    • University of Western Ontario, Canada
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brian Yan, Assistant Professor of Medicine – Lawson Health Research Institute
  • Overall Official(s)
    • Brian M Yan, MD, FRCPC, Principal Investigator, Western University, Canada

Citations Reporting on Results

Oh HC, Seo DW, Song TJ, Moon SH, Park DH, Soo Lee S, Lee SK, Kim MH, Kim J. Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection treats patients with pancreatic cysts. Gastroenterology. 2011 Jan;140(1):172-9. doi: 10.1053/j.gastro.2010.10.001. Epub 2010 Oct 13.

Oh HC, Seo DW, Lee TY, Kim JY, Lee SS, Lee SK, Kim MH. New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008 Apr;67(4):636-42. doi: 10.1016/j.gie.2007.09.038. Epub 2008 Feb 11.

DeWitt J, DiMaio CJ, Brugge WR. Long-term follow-up of pancreatic cysts that resolve radiologically after EUS-guided ethanol ablation. Gastrointest Endosc. 2010 Oct;72(4):862-6. doi: 10.1016/j.gie.2010.02.039.

DeWitt J, McGreevy K, Schmidt CM, Brugge WR. EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.

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