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

This study is currently recruiting participants.
Verified May 2013 by Lawson Health Research Institute
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Brian Yan, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01525706
First received: February 1, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Efficacy: Cyst Resolution [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of patients without cysts at 6 months

  • Efficacy: Degree of Ablation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Degree of cyst epithelial ablation in those undergoing resection


Secondary Outcome Measures:
  • Safety [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    Safety of ethanol/paclitaxel ablation

  • Efficacy: Change of tumor markers [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Change of CEA level in those with persistent/recurrent cyst

  • Efficacy: Cyst Resolution [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Proportion of patients without cysts at 12 months

  • Efficacy: Cyst Resolution [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Proportion of patients without cysts at 18 months

  • Efficacy: Cyst Resolution [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Proportion of patients with no cysts at 24 months


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Ethanol
  • Paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525706

Contacts
Contact: Brian M Yan, MD, FRCPC 519-685-8500 ext 77636 brian.yan@lhsc.on.ca
Contact: Debby Hockin 519-685-8500 ext 77637 Debby.hockin@lhsc.on.ca

Locations
Canada, Ontario
St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Brian M Yan, MD, FRCPC     519-685-8500 ext 77636     brian.yan@lhsc.on.ca    
Principal Investigator: Brian M Yan, MD FRCPC            
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Brian M Yan, MD, FRCPC University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: Brian Yan, Assistant Professor of Medicine, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01525706     History of Changes
Other Study ID Numbers: UWO18494
Study First Received: February 1, 2012
Last Updated: May 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Endoscopic Ultrasound
Pancreatic Mucinous Cystic Neoplasm
Fine Needle Injection
Ethanol Ablation
Paclitaxel Ablation

Additional relevant MeSH terms:
Cystadenocarcinoma
Cystadenocarcinoma, Mucinous
Neoplasms
Cystadenoma
Cystadenoma, Mucinous
Pancreatic Neoplasms
Brain Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous
Adenoma
Digestive System Neoplasms
Neoplasms by Site
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ethanol
Paclitaxel
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013