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.
Additional locations may be listed on ClinicalTrials.gov for NCT06067438.
Locations matching your search criteria
United States
Oregon
Portland
OHSU Knight Cancer InstituteStatus: Active
Contact: Stephanie Wood
Phone: 503-494-6900
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.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationOHSU Knight Cancer Institute
Principal InvestigatorStephanie Wood
