Using antibiotics to prevent infections after esophageal surgery

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)

This study is testing whether using antibiotics to clean the digestive tract can help prevent infections after surgery for esophageal cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 854 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (Academic / other)
• Locations: 2 sites (Leuven and 1 other locations)
• Trial ID: NCT05865743 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary esophageal adenocarcinoma or squamous cell carcinoma scheduled for esophagectomy.

Not a fit: Patients who have undergone upper GI surgery recently or have known allergies to the investigational product may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative infections and improve survival rates for patients undergoing esophagectomy.

How similar studies have performed: Previous studies have shown that SDD can effectively reduce respiratory infections in intensive care settings, suggesting potential success in this novel application.

Eligibility criteria

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 this trial is running

Leuven and 1 other locations

• UZ Leuven — Leuven, Belgium (Recruiting)
• Radboudumc — Nijmegen, Netherlands (Recruiting)

Study contacts

• Principal investigator: Camiel Rosman, Prof — RadoudUMC
• Study coordinator: Justin Grootenhuis, MD

Conditions Esophageal Cancer