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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Amiodarone Hydrochloride
DrugGiven IV and via feeding tube
Saline
Other interventionGiven IV
Treatment groups
Trial outcomes
Primary outcomes
Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone
Will be a binary variable (yes/no) and analyzed using a one-sided test of two proportions at an alpha level of 0.05.
Secondary outcomes
Postoperative (PostOp) rapid ventricular response
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% confidence interval (CI) of the difference between the two proportions.
Postop pulmonary complications
Including pneumonia, acute respiratory distress syndrome, acute pulmonary edema, and chylothorax. Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Anastomotic leak
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
ICU Readmission
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Sponsors and contacts
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