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

Patients receive normal saline IV for 4 days on study.

Amiodarone Hydrochloride

Saline

Stephanie Wood

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.

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

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

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 assessed in days. Analysis: Wilcoxon rank sum test

OHSU Knight Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer	NCT06067438	Atrial Fibrilla... Esophageal Carc...	Amiodarone Hydr... Saline	18 Years -	OHSU Knight Cancer Institute
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer	NCT06067438	Atrial Fibrilla... Esophageal Carc...	Amiodarone Hydr... Saline	18 Years -	OHSU Knight Cancer Institute
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer	NCT06067438	Atrial Fibrilla... Esophageal Carc...	Amiodarone Hydr... Saline	18 Years -	OHSU Knight Cancer Institute

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