Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Recruiting now · Phase 3

Conditions studied: Esophageal Cancer

In brief

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

Key facts

Study ID: NCT05865743
Run by: Radboud University Medical Center
People needed: 854
Starts: 2024-10-21
Expected to finish: 2028-06-30
Last updated by the study team: 2025-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

UZ Leuven — Leuven, Belgium (enrolling)
Radboudumc — Nijmegen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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