Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

Indiana University

Status: Completed

Conditions: Pancreatic Cyst; Papillary Mucinous Cystadenoma, Borderline Malignancy; Pancreatic Intraductal Papillary-Mucinous Neoplasm; Cystadenoma, Mucinous

Treatments: Procedure: 98% Ethanol & Paclitaxel injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01643460

0812-57

Details and patient eligibility

About

The purpose of this study is to track outcomes and complications of patients at IUMC referred by physicians for EUS-guided pancreatic cyst ablation. This information is essential in order to disseminate future published information to physicians about this technique. A database will be created to track these patients undergoing an already scheduled/planned procedure. Phone calls at selected intervals will be made following the procedure to track any complications that occur

Full description

Pancreatic cysts represent a wide spectrum of lesions. Many cysts are uniformly benign (pseudocysts) or have negligible malignant potential (serous cystadenomas). However, others represent premalignant (i.e. intraductal papillary mucinous neoplasms (IPMNs) or mucinous cystadenomas [MCN]), or malignant (i.e. invasive IPMNs or mucinous cystadenocarcinomas) tumors. Management of pancreatic cysts is challenging but surgery is generally recommended for cysts that are symptomatic, premalignant (except possibly branch duct IPMNs) or demonstrate malignancy by imaging features and/or biopsy. However, even in experienced hospitals, surgical resection or enucleation of pancreatic cystic tumors is associated with significant perioperative morbidity and mortality rates of 20-40% and up to 2%, respectively.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients referred between January 2009 and February 2016 to EUS at IUMC for pancreatic cyst ablation and with no contraindications for anticipated safe and successful performance of the procedure.
2. Patient at least 18 years of age.

Exclusion criteria

1. Investigator deems cyst does not meet safety or need for cyst ablation.
2. Subject not competent to sign consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

98% Ethanol with Paclitaxel injection

Experimental group

Treatment:

Procedure: 98% Ethanol & Paclitaxel injection