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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01961778
Other study ID # 2013P001776
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date February 1, 2020

Study information

Verified date January 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 1, 2020
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Radio-Frequency Ablation

Cryotherapy


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
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