CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

Stopped early · Phase 3

Conditions studied: Pancreatic Cyst, EUS-FNA

In brief

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.

Key facts

Study ID

NCT03085004

Run by

Milton S. Hershey Medical Center

People needed

75

Starts

2019-04-12

Expected to finish

2026-02-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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