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Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cyst, Pancreatic Intraductal Papillary-Mucinous Neoplasm, Cystadenoma, Mucinous, Papillary Mucinous Cystadenoma, Borderline Malignancy

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Trial Information

Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts


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.


Inclusion Criteria:



1. Patients referred between January 2009 and February 2012 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cyst resolution

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

John M. DeWitt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Hospital, Indianapolis, IN 46202

Authority:

United States: Institutional Review Board

Study ID:

0812-57

NCT ID:

NCT01643460

Start Date:

September 2009

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Cyst
  • Pancreatic Intraductal Papillary-Mucinous Neoplasm
  • Cystadenoma, Mucinous
  • Papillary Mucinous Cystadenoma, Borderline Malignancy
  • Intraductal papillary mucinous neoplasms (IPMNs)
  • Mucinous cystadenomas [MCN])
  • Invasive IPMNs or mucinous cystadenocarcinomas) tumors
  • Neoplasms
  • Cystadenoma
  • Cystadenoma, Mucinous
  • Cysts
  • Pancreatic Cyst

Name

Location
Indiana University Hospital Indianapolis, Indiana  46202