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NCT05865743 | Not yet recruiting | Esophageal Cancer

Perioperative SDD to Prevent Infectious Complications After Esophagectomy
Sponsor:

Radboud University Medical Center

Brief 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

Condition or disease

Esophageal Cancer

Intervention/treatment

SDD

Phase

Phase 3

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.}}

Study Type : Interventional
Estimated Enrollment : 853 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : 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)
Actual Study Start Date : September 2023
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : December 2027
Arm Intervention/treatment

Experimental: SDD treatment

Standard of care + SDD (an antibiotic drink of 10ml suspension containing amphotericin B (50 mg/ml), colistin sulphate (10 mg/ml), and tobramycin (8 mg/ml)

No Intervention: Standard of care

Standard of care
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 undergoing CVVH.
  • Patients with the inability to swallow the SDD
Perioperative SDD to Prevent Infectious Complications After Esophagectomy

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Perioperative SDD to Prevent Infectious Complications After Esophagectomy

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