Clinical Trial: EUS-guided Ablation of Pancreatic Cyst Neoplasms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cyst Neoplasms

Brief Summary: This is a registry that will maintain prospective data on the clinical outcomes of all patients with pancreatic cyst lesions who undergo EUS-guided alcohol ablation.

Detailed Summary:

Visit 1 for all participants will consist of going over the Informed Consent form and talking with the patient about the study. If the patient agrees to participate, he/she will be asked to sign the form, and a copy will be given to him/her for his/her records. This will be conducted during the day of the endoscopic procedure before the participant is under anesthesia. The treatment provided will be standard-of-care that is offered to patients with pancreatic cyst lesions (PCL) interested in undergoing EUS-guided ethanol ablation.

An MRI of the abdomen will be obtained as baseline measure to determine the size of the pancreatic cyst and confirm diagnosis.

Prior to undertaking any ablation, the cyst fluid will be sampled at a prior EUS session to check for mucin, viscosity, carcinoembryonic antigen (CEA) (>200U/L=mucinous cyst), amylase and if required molecular marker analysis. Once a PCL is determined to have a malignant potential the patient will be selected for EUS-guided ablation. All patients will receive a dose of intravenous ciprofloxacin 500mg 30 minutes prior to the ablation. These evaluation and treatment measures are standard-of-care for any patient with pancreatic cyst lesion undergoing EUS-guided ethanol ablation.

Procedural Technique: All procedures will be undertaken using a curvilinear echoendoscope. Once a cyst is identified for ablation it will be punctured using a 22G needle. After subtotal evacuation of the cyst, injection is performed with a volume of alcohol that is equal to the quantity aspirated, and the cyst will be lavaged for 3 to 5 minutes, alternatively filling and emptying the cavity. The injected ethanol will then be evacuated at the end of lavage, leaving just enough fluid to outline the cavity. A second ablative agent such as paclitaxel i
Sponsor: Florida Hospital

Current Primary Outcome: This study will evaluate the clinical outcomes (effectiveness) of all patients with pancreatic cyst lesions undergoing EUS-guided ethanol ablation. This will include complete resolution of the pancreatic cyst lesion at the end of the treatment period. [ Time Frame: Up to 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Florida Hospital

Dates:
Date Received: February 24, 2015
Date Started: May 2016
Date Completion: December 2018
Last Updated: April 21, 2017
Last Verified: April 2017