Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2022-03-31

Brief Summary

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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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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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98% Ethanol with Paclitaxel injection

Group Type EXPERIMENTAL

98% Ethanol & Paclitaxel injection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Pancreatic cyst injection of Paclitaxel.

Eligibility Criteria

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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.