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

NCT03085004 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-30

No results posted yet for this study

Summary

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

  • Pancreatic Cyst
  • EUS-FNA

Interventions

DRUG

Ethanol

The cyst will be lavaged for 3 to 5 minutes using \>/=99% ethanol as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

DRUG

Normal saline

The cyst will be lavaged for 3 to 5 minutes using normal saline as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.

DRUG

Paclitaxel + Gemcitabine admixture

Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Matthew T. Moyer, MD, MS · Penn State Health Milton S Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2025-12-31
Completion
2026-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085004 on ClinicalTrials.gov