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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 98% Ethanol with Paclitaxel injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 98% Ethanol & Paclitaxel injection | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M. DeWitt, MD | Indiana University Hospital, Indianapolis, IN 46202 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202-5121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27650271 | Derived | Kim KH, McGreevy K, La Fortune K, Cramer H, DeWitt J. Sonographic and cyst fluid cytologic changes after EUS-guided pancreatic cyst ablation. Gastrointest Endosc. 2017 Jun;85(6):1233-1242. doi: 10.1016/j.gie.2016.09.011. Epub 2016 Sep 17. | |
| 24770971 | Derived | DeWitt JM, Al-Haddad M, Sherman S, LeBlanc J, Schmidt CM, Sandrasegaran K, Finkelstein SD. Alterations in cyst fluid genetics following endoscopic ultrasound-guided pancreatic cyst ablation with ethanol and paclitaxel. Endoscopy. 2014 Jun;46(6):457-64. doi: 10.1055/s-0034-1365496. Epub 2014 Apr 25. |
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| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D000077779 | Pancreatic Intraductal Neoplasms |
| D018291 | Cystadenoma, Mucinous |
| D018282 | Cystadenocarcinoma, Mucinous |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 |
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|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D003537 | Cystadenoma |
| D000236 | Adenoma |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D003536 | Cystadenocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |