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

NCT01525706 | Terminated Phase 1

• 1 other identifier: UWO18494
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Efficacy: Cyst Resolution

  Proportion of patients without cysts at 6 months

  6 months

• Efficacy: Degree of Ablation

  Degree of cyst epithelial ablation in those undergoing resection

  6 months

Secondary Outcomes (5)

• Safety

  30 day

• Efficacy: Change of tumor markers

  12 month

• Efficacy: Cyst Resolution

  12 month

• Efficacy: Cyst Resolution

  18 months

• Efficacy: Cyst Resolution

  24 months

Study Arms (1)

Ethanol and Paclitaxel Injection

EXPERIMENTAL

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

Drug: Ethanol and Paclitaxel Injection

Interventions

Ethanol and Paclitaxel Injection 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.

Also known as: Ethanol, Paclitaxel

Ethanol and Paclitaxel Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or fewer cyst compartments
• Age ≥18 and ≤ 85

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (4)

• 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.

  PMID: 20950614 RESULT

• 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.

  PMID: 18262182 RESULT

• 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.

  PMID: 20883866 RESULT

• 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.

  PMID: 19577745 RESULT

MeSH Terms

Interventions

Ethanol; Paclitaxel

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Brian M Yan, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (1)