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Phase 2
18 Years
Open (Enrolling)
Mucinous Pancreatic Cysts

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Trial Information

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.

Inclusion Criteria:

- Patients age 18 and older of any gender, ethnicity and race

- Voluntary enrollment and ability to give written informed consent

- Capable of safely undergoing endoscopy with deep sedation or general anesthesia

- Patients with previously-detected pancreatic cyst(s) 1-5 cm in diameter, including
indeterminate cysts

Exclusion Criteria:

- Pancreatic cyst <1cm or >5cm

- Pancreatic cyst with clear communication with main pancreatic duct

- Clearly benign lesions by clinical and radiographic evaluation (pseudocysts and
serous cystadenomas)

- Known or suspected pancreatic cancer or pathologic lymphadenopathy

- Septated cysts with > 5 compartments

- Coagulopathy (international normalized ratio > 1.6, platelets < 30,000)

- Evidence of active pancreatitis or pancreatic infection

- Patients having undergone endoscopic retrograde cholangiopancreatography (ERCP)
within 72 hours

- Baseline lab values at the time of consent: white blood cells > 14 or < 2,
hematocrit < 30, platelets < 30,000, INR > 1.6, abnormal CA19-9, lipase > 3 times the
upper limit of normal, creatinine > 2.5, ALT > 210, total bilirubin > 2.5, positive
qualitative beta-hCG.

- Any pre-existing or discovered medical condition that may, at the discretion of the
investigator, interfere with the completion of and/or participation in the existing

- Pregnant, breastfeeding, or incarcerated individuals

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in cyst volume

Outcome Description:

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

Outcome Time Frame:

3, 6, and 12 months post procedure

Safety Issue:



United States: Food and Drug Administration

Study ID:

IRB 33751



Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Mucinous Pancreatic Cysts
  • pancreatic cyst
  • chemotherapy
  • ethanol
  • ablation
  • Cysts
  • Pancreatic Cyst



Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033