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

NCT ID: NCT06067438

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2026-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (amiodarone hydrochloride)

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

Group Type: EXPERIMENTAL

Amiodarone Hydrochloride

Intervention Type: DRUG

Given IV and via feeding tube

Arm II (normal saline)

Patients receive normal saline IV for 4 days on study.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Given IV

Interventions

Amiodarone Hydrochloride

Given IV and via feeding tube

Intervention Type: DRUG

Saline

Given IV

Intervention Type: OTHER

Other Intervention Names

Cordarone; Nexterone; ISOTONIC SODIUM CHLORIDE SOLUTION; Sodium Chloride 0.9%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Wood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Wood

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Stephanie Wood

Role: primary

woodste@ohsu.edu

503-494-6900

Other Identifiers

NCI-2023-03642

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00021572

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00021572

Identifier Type: -

Identifier Source: org_study_id