NCT01643460

Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Pancreatic Cyst
• Pancreatic Intraductal Papillary-Mucinous Neoplasm
• Cystadenoma, Mucinous
• Papillary Mucinous Cystadenoma, Borderline Malignancy

Interventions

Type	Name	Description
PROCEDURE	98% Ethanol & Paclitaxel injection	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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2020-12-31
• Completion: 2022-03-31
• First posted: 2012-07-18
• Last updated: 2022-04-14

Locations

1 site across 1 country: United States