The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

Completed · Phase 2

Conditions studied: Mucinous Pancreatic Cysts

In brief

The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.

Key facts

Study ID

NCT01475331

Run by

Milton S. Hershey Medical Center

People needed

46

Starts

2011-11-01

Expected to finish

2017-01-01

Last updated by the study team

2018-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 protocol.
• Pregnant, breastfeeding, or incarcerated individuals

Where it is running

• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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