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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01961778
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
75
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Radio-Frequency Ablation
  • Device: Cryotherapy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Trial Comparing Radiofrequency Ablation and Cryotherapy for the Treatment of Barrett's Esophagus With High-Grade Dysplasia and/or Early Adenocarcinoma
Actual Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Radio-Frequency Ablation

Patients in this arm will receive treatment with radio-frequency ablation.

Device: Radio-Frequency Ablation
Other Names:
  • Barrx

    		•
    Active Comparator: Cryothearpy

    Patients in this arm will receive treatment with cryotherapy.

    Device: Cryotherapy
    Other Names:
  • Trufreeze, CSA Medical

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Barrett's esophagus ablated during the initial treatment session. [2-3 months]

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

    Secondary Outcome Measures

    1. Patient discomfort [2-3 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Norman S Nishioka, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norman Nishioka, MD, Physician, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01961778
    Other Study ID Numbers:
    • 2013P001776
    First Posted:
    Oct 11, 2013
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Adenocarcinoma
    Barrett Esophagus

    Study Results

    No Results Posted as of Jan 12, 2022