Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

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

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Key information

Conditions

Pancreatic Cyst Adenocarcinoma Adenoma Carcinoma Cystadenocarcinoma Cystadenocarcinoma, Mucinous Cystadenoma Cystadenoma, Mucinous Cysts Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Intraductal Neoplasms Pancreatic Intraductal Papillary-Mucinous Neoplasm Pancreatic Neoplasms Papillary Mucinous Cystadenoma, Borderline Malignancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Patient at least 18 years of age.

Exclusion criteria

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

Treatment and study plan

98% Ethanol & Paclitaxel injection

Procedure

Pancreatic cyst injection via Endoscopic Ultrasound (EUS)of 98% Ethanol with Paclitaxel (dose determined in relation to cyst size & amount of fluid aspirated from the cyst.

Other names: Pancreatic cyst injection of Paclitaxel.

Primary outcomes

Cyst resolution

Time frame: 6 months
- Patients will undergo EUS-guided cyst ablation with ethanol +/- paclitaxel as indicated for their scheduled procedure. 2. Patients will return 3 months after initial ablation for a repeat EUS, and ablation will be repeated if cyst size is >10mm in diameter. 3. CT or MRI imaging will be performed 3 months after the second procedure to assess for cyst resolution.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2020
Study completion: 2022
First posted: Jul 18, 2012
Registry last updated: Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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