Overview

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

Status:
Not yet recruiting
Trial end date:
2025-08-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OHSU Knight Cancer Institute
Treatments:
Amiodarone
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Pregnancy

- Negative pregnancy tests are required for participants of childbearing potential
(PCBP) on Day of Surgery (DOS)

- Breastfeeding/chest feeding

- Aborted MIE operation

- QTcB (Bazzett formula) > 500 for heart rate (HR) 60-100 within 30 days