RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy

Quick Facts

Study Start:2024-06-17
Study Completion:2026-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06067438

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients undergoing MIE will be evaluated for potential enrollment
  2. * Indication of cancer, esophageal dysplasia or esophageal dysmotilities
  3. * Age \> 18 years
  4. * Ability to understand and the willingness to sign a written informed consent document
  1. * History of chronic or paroxysmal AF, or atrial flutter
  2. * Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
  3. * Current preoperative use of amiodarone, as baseline home medication
  4. * Development of AF intraoperatively
  5. * Pregnancy
  6. * Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
  7. * Breastfeeding/chest feeding
  8. * Aborted MIE operation
  9. * QTcB (Bazzett formula) \> 500 for heart rate (HR) 60-100 within 30 days

Contacts and Locations

Principal Investigator

Stephanie Wood
PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

  • Stephanie Wood, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17
Study Completion Date2026-08-30

Study Record Updates

Study Start Date2024-06-17
Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Esophageal Carcinoma