The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
1 other identifier
interventional
46
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 8, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
March 20, 2018
CompletedMarch 20, 2018
February 1, 2018
5.2 years
November 8, 2011
January 5, 2018
February 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With the Changing in Cyst Volume
The primary outcome of interest will be change in cyst size, as measured on initial, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution. Cyst size was calculated by measuring x and y diameters and calculating cyst volume using the formula:4/3xpxr3 where r is the average of the cyst radius as measured on the initial, 6-month, and 12-month magnetic resonance imaging or computed tomography. Response was defined according to the same volume percentage reductions as described in previous trials where: complete response is a =\>95% reduction in cyst volume, partial response is a 94%-75% reduction, and anon-response is \<75% reduction in volume.11 The overall ablation rates in both arms were also compared with historical controls to assess the efficacy of the chemotherapeutic cocktail.
6, and 12 months post procedure
Study Arms (2)
Control Group
ACTIVE COMPARATORCyst will be lavaged for 3-5 minutes with Ethanol (alcohol 80%). Following lavage with Ethanol (alcohol 80%), The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.
Study Group
EXPERIMENTALCyst will be lavaged for 3-5 minutes with Normal Saline .. Following lavage with Normal Saline, The cyst will be infused with an admixture of chemotherapy drugs (Paclitaxel/ Gemcitabine) 3mg/ml paclitaxel and 19mg/ml gemcitabine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients age 18 and older of any gender, ethnicity and race
- Voluntary enrollment and ability to give written informed consent
- Capable of safely undergoing endoscopy with deep sedation or general anesthesia
- Patients with previously-detected pancreatic cyst(s) 1-5 cm in diameter, including indeterminate cysts
You may not qualify if:
- Pancreatic cyst \<1cm or \>5cm
- Pancreatic cyst with clear communication with main pancreatic duct
- Clearly benign lesions by clinical and radiographic evaluation (pseudocysts and serous cystadenomas)
- Known or suspected pancreatic cancer or pathologic lymphadenopathy
- Septated cysts with \> 5 compartments
- Coagulopathy (international normalized ratio \> 1.6, platelets \< 30,000)
- Evidence of active pancreatitis or pancreatic infection
- Patients having undergone endoscopic retrograde cholangiopancreatography (ERCP) within 72 hours
- Baseline lab values at the time of consent: white blood cells \> 14 or \< 2, hematocrit \< 30, platelets \< 30,000, INR \> 1.6, abnormal CA19-9, lipase \> 3 times the upper limit of normal, creatinine \> 2.5, ALT \> 210, total bilirubin \> 2.5, positive qualitative beta-hCG.
- Any pre-existing or discovered medical condition that may, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol.
- Pregnant, breastfeeding, or incarcerated individuals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
Moyer MT, Sharzehi S, Mathew A, Levenick JM, Headlee BD, Blandford JT, Heisey HD, Birkholz JH, Ancrile BB, Maranki JL, Gusani NJ, McGarrity TJ, Dye CE. The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol. Gastroenterology. 2017 Nov;153(5):1295-1303. doi: 10.1053/j.gastro.2017.08.009. Epub 2017 Aug 9.
PMID: 28802565DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Because of small number of participants this single-center trial is still weakly powered to show these differences with high levels of scientific certainty.Study was limited to one ablation only.
Results Point of Contact
- Title
- Dr. Matthew T. Moyer
- Organization
- Milton S. Hershey Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 8, 2011
First Posted
November 21, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
March 20, 2018
Results First Posted
March 20, 2018
Record last verified: 2018-02