Cystadenoma, Mucinous, Pancreatic Cyst, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Papillary Mucinous Cystadenoma, Borderline Malignancy
Conditions
Keywords
Intraductal papillary mucinous neoplasms (IPMNs), Mucinous cystadenomas [MCN]), Invasive IPMNs or mucinous cystadenocarcinomas) tumors
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.
Interventions
PROCEDURE98% 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.
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed