Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Trial Title: Perioperative SDD to Prevent Infectious Complications After Esophagectomy

NCT ID: NCT05865743

Condition: Esophageal Cancer

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SDD
Description: The intervention group receives SDD treatment additional to standard care, comprising two distinct liquids for oral administration: first the 5 ml amphotericin B suspension (100 mg/ml) and subsequently the 5 ml "SDD base for suspension", containing both colistin sulphate (20 mg/ml) and tobramycin sulphate (16 mg/ml). Patients take the 5 ml amphotericin B, followed by the 5 ml "SDD base for suspension", four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose.
Arm group label: SDD treatment

Other name: Standard of care

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

Detailed 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.

Criteria for 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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 2024

Completion date: December 2027

Lead sponsor:
Agency: Radboud University Medical Center
Agency class: Other

Collaborator:
Agency: ZonMw: The Netherlands Organisation for Health Research and Development
Agency class: Other

Collaborator:
Agency: Universitaire Ziekenhuizen KU Leuven
Agency class: Other

Source: Radboud University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05865743
https://dica.nl/registratie/maag-en-slokdarmkanker-duca/