Phase 2 N=46 Randomized Double-blind Treatment

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

Mucinous Pancreatic Cysts

Bottom Line

View on ClinicalTrials.gov: NCT01475331 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Mar 2018

Primary outcome: Primary: Number of Participants With the Changing in Cyst Volume — 6; 12; 5; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ethanol (Drug); Normal Saline (Drug); Chemotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With the Changing in Cyst Volume	6; 12; 5; 4; 6; 5	—

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.

Eligibility 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 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 14 or 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01475331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.