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

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

A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy

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.

PRIMARY OBJECTIVE: I. To evaluate the effect of prophylactic amiodarone on the rate of atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE). SECONDARY OBJECTIVES: I. In each subobjective, below, evaluations of the effects of prophylactic amiodarone on the following will be made: Ia. Postoperative (PostOp) rapid ventricular response; Ib. Postop pulmonary complications; Ic. Postop anastomotic leak; Id. Intensive care unit (ICU) readmission; Ie. ICU length of stay (LOS); If. Hospital LOS; Ig. 30-day readmission; Ih. Inpatient mortality; Ii. 30-day mortality; Ij. Adverse events; Ik. Time to AF; Il. Evaluating the association between therapeutic (or serum levels and the development of AF in the experimental group only. EXPLORATORY OBJECTIVE: I. To evaluate the effect of prophylactic amiodarone administration on hospital cost of care. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive amiodarone hydrochloride intravenously (IV) for 4 days and then via a feeding tube for 3 days on study. ARM II: Patients receive placebo (normal saline) IV for 4 days on study. Patients are followed for 60 days following discharge from hospitalization after MIE.

Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study.

Will be a binary variable (yes/no) and analyzed using a one-sided test of two proportions at an alpha level of 0.05.

From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% confidence interval (CI) of the difference between the two proportions.

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.

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

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