Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma

Study Overview
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Brief Summary
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Prospective randomized study comparing radiofrequency ablation and cryotherapy for the endoscopic treatment of Barrett's esophagus. The study is powered to assess clinical equivalence (non-inferior) of the treatment regimens.

Detailed Description
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Adult patients found to be suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus will be asked to participate in this study. Patients will be randomized to receive either radiofrequency ablation or cryotherapy. All treatments will be performed using standard MGH GI Unit protocol. A total of fifty subjects will be enrolled. Patients who have contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) or who decline participation in the study will be ineligible. Patients unable to provide their own consent will also be excluded. This is a single-site study to be conducted at MGH. After obtaining written informed consent, the patient will be randomized to receive either radiofrequency ablation or cryotherapy. Treatments will be carried out in accordance with standard MGH GI Unit practice. The primary endpoint of the study is the percentage of Barrett's esophagus ablated at the first follow-up visit (typically 2-3 months following therapy). At this point, the patient's role in the study will be terminated. They will continue to receive routine follow-up by their physician as needed.

Official Title
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Prospective Randomized Trial Comparing Radiofrequency Ablation and Cryotherapy for the Treatment of Barrett's Esophagus With High-Grade Dysplasia and/or Early Adenocarcinoma

Conditions
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Barrett's Esophagus

Intervention / Treatment
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* Device: Radio-Frequency Ablation
* Device: Cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suitable candidates for endoscopic treatment of Barrett's esophagus (BE) with high-grade dysplasia (HGD) and/or early adenocarcinoma of the esophagus Exclusion Criteria: contraindications to endoscopic treatment (e.g., bleeding diathesis, pregnancy, severe medical comorbidities, advanced liver disease) refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radio-Frequency Ablation<br>Patients in this arm will receive treatment with radio-frequency ablation. | Device: Radio-Frequency Ablation<br> <br> * Other names: Barrx;|
| Active Comparator: Cryothearpy<br>Patients in this arm will receive treatment with cryotherapy. | Device: Cryotherapy<br> <br> * Other names: Trufreeze, CSA Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Barrett's esophagus ablated during the initial treatment session. | The primary endpoint of this study is the percentage of Barrett's esophagus ablated during the initial treatment session. | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort | The degree of patient discomfort (pain, amount of narcotics used) will be assessed during a telephone call to the patient 24-48 hours following the procedure. | 2-3 days |