2009-09
2020-12-31
2022-03-31
33
NCT01643460
Indiana University
Indiana University
INTERVENTIONAL
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
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-06-28 | N/A | 2022-04-06 |
2012-07-17 | N/A | 2022-04-14 |
2012-07-18 | N/A | 2022-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 98% Ethanol with Paclitaxel injection | PROCEDURE: 98% Ethanol & Paclitaxel injection
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Cyst resolution | 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. | 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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