Clinical trial NCT01525706: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: 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
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2012-02-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Efficacy: Cyst Resolution
timeFrame: 6 months
measure: Efficacy: Degree of Ablation
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 30 day
measure: Efficacy: Change of tumor markers
timeFrame: 12 month
measure: Efficacy: Cyst Resolution
timeFrame: 12 month
measure: Efficacy: Cyst Resolution
timeFrame: 18 months
measure: Efficacy: Cyst Resolution
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Brian M Yan, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.