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

OHSU Knight Cancer Institute

Status and phase

Enrolling

Phase 2

Conditions

Esophageal Carcinoma

Atrial Fibrillation

Treatments

Other: Saline

Drug: Amiodarone Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT06067438

NCI-2023-03642 (Registry Identifier)

STUDY00021572 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients undergoing MIE will be evaluated for potential enrollment
- Indication of cancer, esophageal dysplasia or esophageal dysmotilities
Age > 18 years
Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

History of chronic or paroxysmal AF, or atrial flutter
Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
Current preoperative use of amiodarone, as baseline home medication
Development of AF intraoperatively
Pregnancy
- Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
Breastfeeding/chest feeding
Aborted MIE operation
QTcF (Fridericia formula) > 500 for heart rate (HR) 60-100 within 30 days
- For patients with a heart rate (HR) of between 50-59 on their pre-operative screening electrocardiography (EKG), we will first review evidence of chronotropic cardiac response to exercise before inclusion in the study. If a patient's HR increases to ≥ 100 with exercise, the patient is eligible for inclusion of study. Exercise testing options may include a stair climb, a brisk walk, or supine leg-lifts prior to surgery. If exercise is not an option, we can review results of formal stress testing chronotropic response (ie. HR ≥ 100). HR monitoring can be collected by either pulse oximeter or EKG