Perioperative SDD to Prevent Infectious Complications After Esophagectomy (PERSuaDER)

Radboud University Medical Center

Status and phase

Enrolling

Phase 3

Conditions

Esophageal Cancer

Treatments

Drug: SDD

Study type

Interventional

Funder types

Other

Identifiers

NCT05865743

2023-504144-33-00

Details and patient eligibility

About

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

Full 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.

Enrollment

854 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).