Clinical trial · Interventional
The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
NCT01475331CI-TRIAL-00032152completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucinous Pancreatic Cysts | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Ethanol | Drug | — | UNRESOLVED |
| Normal Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Cyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.
- interventionNames
- Drug: Ethanol
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Study Group
- description
- Cyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.
- interventionNames
- Drug: Normal Saline
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMoyer MT, Sharzehi S, Mathew A, Levenick JM, Headlee BD, Blandford JT, Heisey HD, Birkholz JH, Ancrile BB, Maranki JL, Gusani NJ, McGarrity TJ, Dye CE. The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol. Gastroenterology. 2017 Nov;153(5):1295-1303. doi: 10.1053/j.gastro.2017.08.009. Epub 2017 Aug 9. PMID 28802565