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 in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo (normal saline) IV for 4 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 60 days following discharge from hospitalization after MIE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
90
Given IV and via feeding tube
Given IV
OHSU Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGDevelopment 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.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone
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.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital.
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.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30
Anastomotic leak
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30
ICU Readmission
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30
ICU length of stay (LOS)
Will be assessed in days. Analysis: Wilcoxon rank sum test
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU
Hospital LOS
Will be assessed in days. Analysis: Wilcoxon rank sum test
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital
30 Day readmission rate
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Time frame: Day of discharge (DC) from hospital to 30 days after discharge
Inpatient morality
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital
Incidence of mortality within 30 days of surgery
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30
Incidence and type of adverse events
Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30
Time to AF
Analysis: Log-rank test.
Time frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7
Serum amiodarone level, classified as therapeutic or subtherapeutic
Time frame: Post-operative day (POD) 2 to post-operative day (POD) 3
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