While about half of pancreatic cystic lesions have little to no malignant potential,
mucinous cystic neoplasms (MCNs) and intraductal papillary mucinous neoplasms (IPMNs) carry
a high potential for progression into pancreatic cancer. Therefore, either close
radiographic surveillance or surgical resection is generally recommended for these cysts.
However, pancreatic surgery is associated with a significant risk of morbidity and mortality
and not all patients are good surgical candidates. As an alternative, endoscopic
ultrasound-guided fine needle injection(EUS-FNI) has been shown to be moderately effective
in ablating cystic lesions.
The goal of this investigation is to improve the efficacy and safety of this procedure when
compared with previous versions of the technique. This study is designed to evaluate the
efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of
pancreatic cystic neoplasms using EUS-FNI for agent delivery. This paired, prospective,
double-blind, randomized study will include 78 patients referred to the Penn State Hershey
Medical Center. Mucinous or indeterminate pancreatic cysts of 1-5cm with less than 5
compartments and without clear communication with the main pancreatic duct will be included.
Patients will be randomized in a 1:1 ratio into a control arm or study arm. Patients
randomized to the control arm will receive ethanol lavage of the cyst followed by injection
of two carefully selected chemotherapeutic agents. Study arm patients will receive a normal
saline lavage followed by injection of the same chemotherapy admixture. Patients will be
monitored for 2 hours post-procedure, and a follow-up CT will be performed at 3, 6, and 12
months, or as determined necessary to evaluate cyst resolution. Patients may elect to
undergo evaluation for surgical resection at any time, regardless of response, in which case
a dedicated pathologist will evaluate any surgical specimens.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Change in cyst volume
The primary outcome of interest will be change in cyst size, as measured on initial, 3, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution
3, 6, and 12 months post procedure
United States: Food and Drug Administration
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