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Phase II/III Study of Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: a Prospective, Randomized, Double-blind, Multi-center Clinical Trial (CHARM II)

Summary

The purpose of this phase II/III study is to evaluate the efficacy of chemotherapeutic pancreatic cyst ablation using ethanol lavage followed by the infusion of a single agent chemotherapeutic agent (paclitaxel) compared with alcohol free, saline lavage followed by infusion of a multi-agent chemotherapeutic cocktail (paclitaxel + gemcitabine) for the ablation of pancreatic cystic neoplasms using endoscopic ultrasound fine needle infusion (EUS-FNI) for agent delivery. The ultimate purpose is a safe and more effective EUS-FNI method to eliminate there pre-cancerous cyst and prevent a significant percentage of pancreatic cancer.

General Information

NCT#: NCT03085004
Study ID: IRB5206
Trial Phase: Phase II/III

Trial Sponsor: Penn State University
Therapies Used in This Trial: Gemcitabine, Paclitaxel, Ethanol

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