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

NCT ID: NCT01525706

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mucinous Cystic Tumor With Moderate Dysplasia Mucinous Cystadenoma of Pancreas Mucinous Cystadenocarcinoma of Pancreas Benign Neoplasm of Pancreas

Keywords

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Endoscopic Ultrasound Pancreatic Mucinous Cystic Neoplasm Fine Needle Injection Ethanol Ablation Paclitaxel Ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ethanol and Paclitaxel Injection

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

Group Type EXPERIMENTAL

Ethanol and Paclitaxel Injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Ethanol Paclitaxel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Brian Yan

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian M Yan, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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St. Joseph's Health Care

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 20950614 (View on PubMed)

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.

Reference Type RESULT
PMID: 18262182 (View on PubMed)

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.

Reference Type RESULT
PMID: 20883866 (View on PubMed)

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.

Reference Type RESULT
PMID: 19577745 (View on PubMed)

Other Identifiers

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UWO18494

Identifier Type: -

Identifier Source: org_study_id