Clinical trial · Interventional
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: a Prospective, Randomized, Double-blind, Multi-center Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Grant ended
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) compared with alcohol-free saline lavage followed by infusion of the same dual-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound guided fine needle infusion (EUS-FNI) for agent delivery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EUS-FNA | — | UNRESOLVED | — |
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethanol | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
| Paclitaxel + Gemcitabine admixture | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Cyst will be lavaged for 3 to 5 minutes with \>/=99% ethanol. Following lavage with \>/=99% ethanol, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).
- interventionNames
- Drug: Ethanol
- Drug: Paclitaxel + Gemcitabine admixture
- type
- EXPERIMENTAL
- label
- Study group
- description
- Cyst will be lavaged for 3 to 5 minutes with normal saline. Following lavage with normal saline, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).
- interventionNames
- Drug: Normal saline
- Drug: Paclitaxel + Gemcitabine admixture
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects over the age of 18. * Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts. * Able to give written informed consent. * Capable of safely undergoing endoscopy with deep sedation or general anesthesia. Exclusion Criteria: * Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines (i.e., consistent with a pseudocyst or serous cystadenoma). * Known or suspected pancreatic cancer or pathologic lymphadenopathy. * Cysts with the following high-risk features: main pancreatic duct dilation of \> 5mm, epithelial type mural nodules (\> 2mm)33, pathologically thick wall/septation (\> 2mm), cytology showing high grade dysplasia or "suspicious for malignancy", signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst (\> 2mm), pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity. (Of note, the following higher-risk features ARE eligible: recent growth in size, atypical cells on cytology, and symptoms referable to the pancreas.) * Septated cysts with \> 4 compartments. * Confirmed acute pancreatitis within the last 6 months. * Baseline lab values (must be within 6 months of consent date) in the following ranges: white blood cells \> 14 or \< 2 K/uL, hematocrit \<30%, platelets \<30 K/uL, non-pharmacologic INR \>1.7, CA19-9 \>2x ULN, lipase \>2x ULN, creatinine \>3.0 mg/dl (unless stable on renal replacement therapy), ALT \>500 U/L, total bilirubin \>2.5 mg/dl. * Any pre-existing or discovered medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol. This includes severe pre-existing medical conditions which would preclude a reasonable 5 year life expectancy (and thus neutralize the patient's benefit from ablating a premalignant type pancreatic cyst). * Pregnancy, breastfeeding, or incarcerated individual.
References
Publications (0)
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