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

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ClinicalTrials.gov Identifier: NCT01525706
Recruitment Status : Terminated (Poor recruitment)
First Posted : February 3, 2012
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Brian Yan, Lawson Health Research Institute

Study Description
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Brief 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.


Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
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
Study Start Date : September 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: Cyst Resolution [ Time Frame: 6 months ]
    Proportion of patients without cysts at 6 months

  2. Efficacy: Degree of Ablation [ Time Frame: 6 months ]
    Degree of cyst epithelial ablation in those undergoing resection


Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 day ]
    Safety of ethanol/paclitaxel ablation

  2. Efficacy: Change of tumor markers [ Time Frame: 12 month ]
    Change of CEA level in those with persistent/recurrent cyst

  3. Efficacy: Cyst Resolution [ Time Frame: 12 month ]
    Proportion of patients without cysts at 12 months

  4. Efficacy: Cyst Resolution [ Time Frame: 18 months ]
    Proportion of patients without cysts at 18 months

  5. Efficacy: Cyst Resolution [ Time Frame: 24 months ]
    Proportion of patients with no cysts at 24 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525706


Locations
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Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
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Principal Investigator: Brian M Yan, MD, FRCPC University of Western Ontario, Canada
More Information
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Publications of Results:

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Responsible Party: Brian Yan, Assistant Professor of Medicine, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01525706    
Other Study ID Numbers: UWO18494
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Keywords provided by Brian Yan, Lawson Health Research Institute:
Endoscopic Ultrasound
Pancreatic Mucinous Cystic Neoplasm
Fine Needle Injection
Ethanol Ablation
Paclitaxel Ablation
Additional relevant MeSH terms:
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Neoplasms
Cystadenocarcinoma
Cystadenocarcinoma, Mucinous
Cystadenoma
Cystadenoma, Mucinous
Pancreatic 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
Ethanol
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants