RecruitingPhase 3NCT05865743

Perioperative SDD to Prevent Infectious Complications After Esophagectomy

PERi-operative Selective Decontamination of the Digestive Tract to Prevent Severe Infectious Complications After Esophagectomy: a Randomized Multicenter Clinical Trial in Patients with Primary Resectable Esophageal Carcinoma (cT1-4, N0-3, M0)

Sponsor

Radboud University Medical Center

Enrollment

854 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer

Summary

The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving antibiotic and antifungal decontamination treatments to the gut and mouth before and after esophageal cancer surgery (esophagectomy) can reduce the risk of infections — a common complication. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with esophageal adenocarcinoma or squamous cell carcinoma and are scheduled for esophageal surgery with the intent to cure - You are able to swallow oral medications - You are able to give written informed consent **You may NOT be eligible if...** - You are having emergency (rescue) surgery - You are pregnant or at risk of pregnancy - You have had upper digestive surgery in the past 30 days - You have severe kidney failure or are on dialysis - You have a known allergy to the study medications - You have neuromuscular diseases like myasthenia gravis or Parkinson's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSDD

The intervention group receives SDD treatment additional to standard care, comprising two distinct liquids for oral administration: first the 5 ml amphotericin B suspension (100 mg/ml) and subsequently the 5 ml "SDD base for suspension", containing both colistin sulphate (20 mg/ml) and tobramycin sulphate (16 mg/ml). Patients take the 5 ml amphotericin B, followed by the 5 ml "SDD base for suspension", four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose.