About this trial
This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.
Eligibility criteria
Qualifiers
All patients undergoing MIE will be evaluated for potential enrollment
Indication of cancer, esophageal dysplasia or esophageal dysmotilities
Age > 18 years
Ability to understand and the willingness to sign a written informed consent document
Disqualifiers
History of chronic or paroxysmal AF, or atrial flutter
Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
Current preoperative use of amiodarone, as baseline home medication
Development of AF intraoperatively
Trial design
Treatments tested in this trial
- Amiodarone Hydrochloride
- Saline
Treatment groups
Locations
1Sponsors and collaborators
OHSU Knight Cancer Institute
Lead sponsor