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RecruitingPhase 2NCT06067438

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

Sponsor

OHSU Knight Cancer Institute

Enrollment

90 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal CarcinomaAtrial Fibrillation

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving amiodarone (a heart rhythm medication) during and after minimally invasive esophageal surgery (esophagectomy) can prevent atrial fibrillation (AFib) — an irregular heart rhythm that commonly occurs as a complication of this major surgery in patients with esophageal cancer. **You may be eligible if...** - You are over 18 and having minimally invasive surgery (MIE) for esophageal cancer, dysplasia, or esophageal motility disorders - You do not have a history of AFib or atrial flutter - You have no known contraindications to amiodarone **You may NOT be eligible if...** - You have a history of atrial fibrillation or flutter - You have had a serious reaction to amiodarone before, or have thyroid, liver, or lung problems that make amiodarone unsafe - You are currently taking amiodarone as a regular medication - You are pregnant or breastfeeding - Your surgery was incomplete (aborted) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmiodarone Hydrochloride

Given IV and via feeding tube

OTHERSaline

Given IV

Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

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NCT06067438

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