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NCT01525706 Clinical Trial

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

Benign Neoplasm of Pancreas Clinical Trial

Official title:
EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01525706
Other study ID # UWO18494
Secondary ID
Status Terminated
Phase Phase 1
First received February 1, 2012
Last updated November 1, 2016
Start date September 2012
Est. completion date November 2016

Study information
Verified date November 2016
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada St. Joseph's Health Care London Ontario

Sponsors (2)
Lead Sponsor Collaborator
Lawson Health Research Institute University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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.20 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy: Cyst Resolution Proportion of patients without cysts at 6 months 6 months No
Primary Efficacy: Degree of Ablation Degree of cyst epithelial ablation in those undergoing resection 6 months No
Secondary Safety Safety of ethanol/paclitaxel ablation 30 day Yes
Secondary Efficacy: Change of tumor markers Change of CEA level in those with persistent/recurrent cyst 12 month No
Secondary Efficacy: Cyst Resolution Proportion of patients without cysts at 12 months 12 month No
Secondary Efficacy: Cyst Resolution Proportion of patients without cysts at 18 months 18 months No
Secondary Efficacy: Cyst Resolution Proportion of patients with no cysts at 24 months 24 months No