Actively Recruiting
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
Led by OHSU Knight Cancer Institute · Updated on 2025-09-23
90
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing minimally invasive esophagectomy (MIE) for esophageal cancer, esophageal dysplasia, or esophageal dysmotilities
- Age over 18 years
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- History of chronic or paroxysmal atrial fibrillation or atrial flutter
- Previous severe reaction or contraindication to amiodarone (such as lung toxicity, liver toxicity, or thyroid problems)
- Current use of amiodarone before surgery
- Development of atrial fibrillation during surgery
- Pregnancy (negative pregnancy test required on surgery day for those who can become pregnant)
- Breastfeeding
- Aborted minimally invasive esophagectomy operation
- QTcF (heart rate corrected QT interval) over 500 within 30 days prior to surgery
- For heart rate 50-59 bpm on pre-op EKG, must show heart rate increases to 100 or more with exercise to be eligible
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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