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

What this Trial Is About

This research aims to evaluate how well amiodarone works to prevent atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. AF is an irregular and often rapid heart rhythm caused by abnormal electrical signals in the heart's upper chambers and is the most common complication after MIE. Currently, there is no standard guideline for using preventive medications like amiodarone in this setting, and many centers do not use it after esophagectomy. This study hopes to determine if giving amiodarone can reduce the risk of AF in these patients. Participants are randomly assigned to one of two groups. One group receives amiodarone hydrochloride through an IV for 4 days followed by administration via a feeding tube for 3 days, provided there is no disease progression or unacceptable side effects. The other group receives a placebo (normal saline) through an IV for 4 days. Patients are monitored during the hospital stay and followed for 60 days after discharge. During the study, researchers will closely track the development of AF from the start of amiodarone treatment until seven days after surgery. They will also assess other outcomes including rapid heart rate responses, lung complications, anastomotic leaks, ICU readmissions and length of stay, overall hospital stay, readmission within 30 days, mortality rates in the hospital and at 30 days, adverse events, and the timing of AF onset. Serum amiodarone levels will be measured to study their relationship with AF. The study includes safety follow-up and cost evaluations related to hospital care.

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