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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Ethanol

Criteria

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 protocol.

• Pregnant, breastfeeding, or incarcerated individuals