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

Phase 1

Terminated

• Conditions: Mucinous Cystic Tumor With Moderate Dysplasia; Mucinous Cystadenocarcinoma of Pancreas; Benign Neoplasm of Pancreas; Mucinous Cystadenoma of Pancreas
• Interventions: Drug: Ethanol and Paclitaxel Injection

• Registration Number: NCT01525706
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Study Start: 2012-09
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ethanol and Paclitaxel Injection	Ethanol and Paclitaxel Injection	All patients will receive at least one treatment with alcohol and paclitaxel.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety	30 day	Safety of ethanol/paclitaxel ablation
Efficacy: Change of tumor markers	12 month	Change of CEA level in those with persistent/recurrent cyst
Efficacy: Cyst Resolution	24 months	Proportion of patients with no cysts at 24 months

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada