NCT06067438

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Atrial Fibrillation
• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Amiodarone Hydrochloride	Given IV and via feeding tube
OTHER	Saline	Given IV

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2023-10-04
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study