Status:
COMPLETED
The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Mucinous Pancreatic Cysts
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-guid...
Detailed Description
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01475331
Start Date
November 1 2011
End Date
January 1 2017
Last Update
March 20 2018
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033