Using antibiotics to prevent infections after esophageal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PERSuaDER-trial aims to evaluate the effectiveness of selective decontamination of the digestive tract (SDD) in preventing infectious complications, particularly pneumonia, following esophagectomy for esophageal cancer. This phase 3 interventional study focuses on patients diagnosed with primary esophageal adenocarcinoma or squamous cell carcinoma who are scheduled for surgery. By reducing pathogenic bacteria while preserving protective microbiota, SDD seeks to lower the risk of postoperative infections and improve survival rates. The trial will compare outcomes between patients receiving SDD and those receiving standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
* Age ≥ 18 years,
* Able to give written informed consent.

Exclusion Criteria:

* Patients planned for rescue surgery,
* Patients planned for colonic interposition,
* Known or suspected pregnancy,
* Patients who have undergone upper GI surgery within 30 days before randomization,
* Unable to understand the study information, study instructions and give informed consent.
* Patients enrolled in a trial that would interact with the intervention
* Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
* Patients with known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
* Patients undergoing CVVH.
* Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
* Women of childbearing potential at risk of pregnancy, not using adequate contraception,
* Patients with the inability to swallow the SDD
* Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting
• Radboudumc
  Nijmegen, Netherlands Recruiting

Study contacts

• Principal investigator: Camiel Rosman, Prof — RadoudUMC
• Study coordinator: Justin Grootenhuis, MD
• Email: justin.grootenhuis@radboudumc.nl
• Phone: +31655740313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.