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Amiodarone for Atrial Fibrillation Prevention in Esophageal Cancer Surgery

Phase 2

Recruiting

Led By Stephanie Wood

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Indication of cancer, esophageal dysplasia or esophageal dysmotilities

Must not have

Aborted MIE operation

History of chronic or paroxysmal AF, or atrial flutter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of discharge (dc) from hospital to 30 days after discharge

Summary

This trial studies if amiodarone can reduce risk of irregular heart rhythm after esophageal cancer surgery.

Who is the study for?

This trial is for adults over 18 with esophageal cancer or related conditions who are undergoing minimally invasive esophagectomy (MIE). They must understand and consent to the study. Excluded are pregnant or breastfeeding individuals, those with certain heart rate irregularities, current amiodarone users, patients developing AF during surgery, and anyone with a history of adverse reactions to amiodarone.

What is being tested?

The trial is testing if amiodarone can prevent atrial fibrillation—a common irregular heartbeat—after MIE in esophageal cancer patients. Participants will be randomly assigned to receive either amiodarone or saline as a control after their surgery to see which works better at preventing AF.

What are the potential side effects?

Amiodarone may cause side effects such as lung issues like fibrosis, liver toxicity, thyroid problems, and changes in heart rhythm. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have cancer, esophageal dysplasia, or trouble swallowing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My minimally invasive esophagectomy was stopped.

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I have a history of irregular heartbeats.

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I am currently taking amiodarone as part of my regular medication.

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I have had a severe reaction or cannot take amiodarone due to lung, liver, or thyroid issues.

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I developed atrial fibrillation during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation of amiodarone in the intensive care unit (icu) to time of discharge from hospital

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation of amiodarone in the intensive care unit (icu) to time of discharge from hospital

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of amiodarone in the intensive care unit (icu) to time of discharge from hospital for reporting.