Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

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

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators