Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05865743

Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Led by Radboud University Medical Center · Updated on 2025-03-05

854

Participants Needed

2

Research Sites

192 weeks

Total Duration

On this page

Sponsors

R

Radboud University Medical Center

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

Perioperative SDD to Prevent Infectious Complications After Esophagectomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the gastro-esophageal junction
  • Scheduled for transthoracic esophagectomy or esophageal reconstruction with gastric or jejunal interposition
  • Age 18 years or older
  • Able to give written informed consent
Not Eligible

You will not qualify if you...

  • Planned for rescue surgery
  • Planned for colonic interposition
  • Known or suspected pregnancy
  • Upper GI surgery within 30 days before randomization
  • Unable to understand study information and give informed consent
  • Enrolled in a conflicting clinical trial
  • Known allergy or sensitivity to study medications
  • Colonization with bacteria resistant to tobramycin/gentamicin and carbapenem antibiotics
  • Undergoing continuous venovenous hemofiltration (CVVH)
  • Chronic renal failure with GFR < 15 mls/min or on dialysis
  • Women of childbearing potential not using adequate contraception
  • Inability to swallow the study medication
  • Pre-existing degenerative neuromuscular diseases such as myasthenia gravis or Parkinson's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

2

Radboudumc

Nijmegen, Netherlands, 6525GA

Actively Recruiting

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Research Team

J

Justin Grootenhuis, MD

CONTACT

R

Research Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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