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

November 1, 2016 updated by: Brian Yan, Lawson Health Research Institute

EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Cyst Resolution
Time Frame: 6 months
Proportion of patients without cysts at 6 months
6 months
Efficacy: Degree of Ablation
Time Frame: 6 months
Degree of cyst epithelial ablation in those undergoing resection
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 30 day
Safety of ethanol/paclitaxel ablation
30 day
Efficacy: Change of tumor markers
Time Frame: 12 month
Change of CEA level in those with persistent/recurrent cyst
12 month
Efficacy: Cyst Resolution
Time Frame: 12 month
Proportion of patients without cysts at 12 months
12 month
Efficacy: Cyst Resolution
Time Frame: 18 months
Proportion of patients without cysts at 18 months
18 months
Efficacy: Cyst Resolution
Time Frame: 24 months
Proportion of patients with no cysts at 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Brian M Yan, MD, FRCPC, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWO18494

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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