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

Lawson Health Research Institute

Status and phase: Terminated; Phase 1

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

Treatments: Drug: Ethanol and Paclitaxel Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01525706

UWO18494

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Ethanol and Paclitaxel Injection

Experimental group

Description:

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

Treatment:

Drug: Ethanol and Paclitaxel Injection