Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Last updated: February 28, 2025
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Esophageal Cancer

Treatment

SDD

Clinical Study ID

NCT05865743
2023-504144-33-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 thegastro-esophageal junction scheduled for undergoing transthoracic esophagectomy withcurative intent or for esophageal reconstruction with a gastric or jejunalinterposition

  • Age ≥ 18 years,

  • Able to give written informed consent.

Exclusion

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 informedconsent.

  • Patients enrolled in a trial that would interact with the intervention

  • Patients with a known allergy, sensitivity, or interaction to investigationalmedicinal product.

  • Patients with known/documented colonization of Enterobacteriaceae and or PseudomonasAeruginosa that are resistant to both tobramycin/gentamicin and to carbapenemantibiotics

  • Patients undergoing CVVH.

  • Patients with documented chronic renal failure (GFR < 15 mls/min) or who are onchronic intermittent hemo- or peritoneal dialysis,

  • Women of childbearing potential at risk of pregnancy, not using adequatecontraception,

  • Patients with the inability to swallow the SDD

  • Patients with pre-existing degenerative neuromuscular diseases like, but not limitedto, myasthenia gravis or Parkinson disease).

Study Design

Total Participants: 854
Treatment Group(s): 1
Primary Treatment: SDD
Phase: 3
Study Start date:
October 21, 2024
Estimated Completion Date:
June 30, 2028

Study Description

Esophagectomy is a complex surgical procedure, associated with significant morbidity and mortality rates. Most postoperative complications are caused by infections (10-30%). These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract, leading to (respiratory) infections. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy that aims to prevent postoperative infections. Pathogenic aerobic gram-negative rods and yeasts tract are reduced, while anaerobic, protective microbiota are preserved. SDD has been shown to lower the risk for respiratory infections in an intensive care setting. Establishing SDD as effective addition to the standard care of esophagectomy patients is expected to increase their chance of survival.

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Radboudumc

    Nijmegen, 6525GA
    Netherlands

    Active - Recruiting

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