The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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While about half of pancreatic cystic lesions have little to no malignant potential, mucinous cystic neoplasms (MCNs) and intraductal papillary mucinous neoplasms (IPMNs) carry a high potential for progression into pancreatic cancer. Therefore, either close radiographic surveillance or surgical resection is generally recommended for these cysts. However, pancreatic surgery is associated with a significant risk of morbidity and mortality and not all patients are good surgical candidates. As an alternative, endoscopic ultrasound-guided fine needle injection(EUS-FNI) has been shown to be moderately effective in ablating cystic lesions.

The goal of this investigation is to improve the efficacy and safety of this procedure when compared with previous versions of the technique. This study is designed to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of pancreatic cystic neoplasms using EUS-FNI for agent delivery. This paired, prospective, double-blind, randomized study will include 78 patients referred to the Penn State Hershey Medical Center. Mucinous or indeterminate pancreatic cysts of 1-5cm with less than 5 compartments and without clear communication with the main pancreatic duct will be included. Patients will be randomized in a 1:1 ratio into a control arm or study arm. Patients randomized to the control arm will receive ethanol lavage of the cyst followed by injection of two carefully selected chemotherapeutic agents. Study arm patients will receive a normal saline lavage followed by injection of the same chemotherapy admixture. Patients will be monitored for 2 hours post-procedure, and a follow-up CT will be performed at 6, and 12 months, or as determined necessary to evaluate cyst resolution. Patients may elect to undergo evaluation for surgical resection at any time, regardless of response, in which case a dedicated pathologist will evaluate any surgical specimens.

Conditions

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Mucinous Pancreatic Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

Cyst 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.

Group Type ACTIVE_COMPARATOR

Ethanol

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

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.

Study Group

Cyst 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.

Group Type EXPERIMENTAL

Normal Saline

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

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.

Interventions

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Ethanol

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

Intervention Type DRUG

Normal Saline

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

Intervention Type DRUG

Chemotherapy

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No