Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

Not Applicable

Completed

• Conditions: Pancreatic Cyst; Pancreatic Intraductal Papillary-Mucinous Neoplasm; Cystadenoma, Mucinous; Papillary Mucinous Cystadenoma, Borderline Malignancy
• Interventions: Procedure: 98% Ethanol & Paclitaxel injection

• Registration Number: NCT01643460
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Primary Completion: 2020-12-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
98% Ethanol with Paclitaxel injection	98% Ethanol & Paclitaxel injection	-

Primary Outcome Measures

Name	Time	Method
Cyst resolution	6 months	1. 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.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States