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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
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

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Erasme
Coordinator of this site? Confirm its status
AnderlechtBelgiumRecruiting
Antwerp University Hospital
Coordinator of this site? Confirm its status
EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
AZ Delta
Coordinator of this site? Confirm its status
RoeselareBelgiumRecruiting
Chu Ucl Namur
Coordinator of this site? Confirm its status
YvoirBelgiumRecruiting
Ziekenhuisgroep Twente Stichting
Coordinator of this site? Confirm its status
AlmeloNetherlandsRecruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Catharina Ziekenhuis Stichting
Coordinator of this site? Confirm its status
EindhovenNetherlandsRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Zuyderland Medisch Centrum Stichting
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HeerlenNetherlandsRecruiting
Medisch Centrum Leeuwarden B.V.
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LeeuwardenNetherlandsRecruiting
Leids Universitair Medisch Centrum (LUMC)
Coordinator of this site? Confirm its status
LeidenNetherlandsRecruiting
Stichting Radboud University Medical Center
Coordinator of this site? Confirm its status
NijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Elisabeth-Tweesteden Ziekenhuis
Coordinator of this site? Confirm its status
TilburgNetherlandsRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.