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Clinical Trials/NCT01961778
NCT01961778
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country50 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Barrett's Esophagus
Sponsor
Massachusetts General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Percentage of Barrett's esophagus ablated during the initial treatment session.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
February 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Norman Nishioka, MD

Physician

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Barrett's esophagus ablated during the initial treatment session.

Time Frame: 2-3 months

The primary endpoint of this study is the percentage of Barrett's esophagus ablated during the initial treatment session.

Secondary Outcomes

  • Patient discomfort(2-3 days)

Study Sites (1)

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