Clinical trial NCT01643460: Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
Official title: Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cyst
Pancreatic Intraductal Papillary-Mucinous Neoplasm
Cystadenoma, Mucinous
Papillary Mucinous Cystadenoma, Borderline Malignancy
Keywords: Intraductal papillary mucinous neoplasms (IPMNs)
Mucinous cystadenomas [MCN])
Invasive IPMNs or mucinous cystadenocarcinomas) tumors
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cyst resolution
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Hospital, Indianapolis, IN 46202
name: John M. DeWitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.