CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Ethanol +2 moredrug
Likely dose
Chemotherapy 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01475331
NCT01475331Phase 2Completed
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The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

Milton S. Hershey Medical Center·interventional·Posted Nov 21, 2011·Updated Mar 20, 2018

In Brief

A Phase 2 clinical trial evaluating Ethanol, Normal Saline, and 1 other intervention for Mucinous Pancreatic Cysts. Completed, enrolled 46 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucinous Pancreatic Cysts
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.6 years ago

Interventions

Ethanoldrug

Cysts will be lavaged for 3-5 minutes with 80% EtOH

Normal Salinedrug

Cysts will be lavaged for 3-5 minutes with normal saline

Chemotherapydrug

Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.