NCT05865743RecruitingPhase 3
Perioperative SDD to Prevent Infectious Complications After Esophagectomy
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)
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 854 (estimated)
- First submitted
- 25 Apr 2023
- Start date
- 21 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05865743
- EU CT number
- 2023-504144-33-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 854
- From 21 Oct 2024 to the primary completion date, 31 Dec 2027
- 16 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients planned for rescue surgery,
- Patients who have undergone upper GI surgery within 30 days before randomization,
Other illness
- Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
- Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).
Lab values
- Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
Other
- Patients planned for colonic interposition,
- Known or suspected pregnancy,
- 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 known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
- Patients undergoing CVVH.
- Women of childbearing potential at risk of pregnancy, not using adequate contraception,
- Patients with the inability to swallow the SDD
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Chu Ucl Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Ziekenhuisgroep Twente Stichting Coordinator of this site? Confirm its status | Almelo | Netherlands | Recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Heerlen | Netherlands | Recruiting |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.