search
Back to results

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

Primary Purpose

Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Ethanol and Paclitaxel Injection
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucinous Cystic Tumor With Moderate Dysplasia focused on measuring Endoscopic Ultrasound, Pancreatic Mucinous Cystic Neoplasm, Fine Needle Injection, Ethanol Ablation, Paclitaxel Ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Health Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ethanol and Paclitaxel Injection

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety
Safety of ethanol/paclitaxel ablation
Efficacy: Change of tumor markers
Change of CEA level in those with persistent/recurrent cyst
Efficacy: Cyst Resolution
Proportion of patients without cysts at 12 months
Efficacy: Cyst Resolution
Proportion of patients without cysts at 18 months
Efficacy: Cyst Resolution
Proportion of patients with no cysts at 24 months

Full Information

First Posted
February 1, 2012
Last Updated
November 1, 2016
Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT01525706
Brief Title
Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
Official Title
EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucinous Cystic Tumor With Moderate Dysplasia, Mucinous Cystadenoma of Pancreas, Mucinous Cystadenocarcinoma of Pancreas, Benign Neoplasm of Pancreas
Keywords
Endoscopic Ultrasound, Pancreatic Mucinous Cystic Neoplasm, Fine Needle Injection, Ethanol Ablation, Paclitaxel Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethanol and Paclitaxel Injection
Arm Type
Experimental
Arm Description
All patients will receive at least one treatment with alcohol and paclitaxel.
Intervention Type
Drug
Intervention Name(s)
Ethanol and Paclitaxel Injection
Other Intervention Name(s)
Ethanol, Paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy: Cyst Resolution
Description
Proportion of patients without cysts at 6 months
Time Frame
6 months
Title
Efficacy: Degree of Ablation
Description
Degree of cyst epithelial ablation in those undergoing resection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety
Description
Safety of ethanol/paclitaxel ablation
Time Frame
30 day
Title
Efficacy: Change of tumor markers
Description
Change of CEA level in those with persistent/recurrent cyst
Time Frame
12 month
Title
Efficacy: Cyst Resolution
Description
Proportion of patients without cysts at 12 months
Time Frame
12 month
Title
Efficacy: Cyst Resolution
Description
Proportion of patients without cysts at 18 months
Time Frame
18 months
Title
Efficacy: Cyst Resolution
Description
Proportion of patients with no cysts at 24 months
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Cyst size > 15mm but <50mm 3 or fewer cyst compartments Age ≥18 and ≤ 85 Exclusion Criteria: Inability to safely undergo EUS examination with standard conscious sedation Inability for safe FNA needle insertion into the cyst (eg: intervening vessel) Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia) Coagulopathy (INR>1.5 or platelets<50) Active pancreatitis or pancreatic infection Active sepsis/bacteremia Inability to provide informed consent Pregnancy Breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Yan, MD, FRCPC
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20950614
Citation
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.
Results Reference
result
PubMed Identifier
18262182
Citation
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.
Results Reference
result
PubMed Identifier
20883866
Citation
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.
Results Reference
result
PubMed Identifier
19577745
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs