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

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: University of Western Ontario, Canada
• Treatments: Albumin-Bound Paclitaxel; Ethanol; Paclitaxel

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