Zusammenfassung (Niederländisch oder Französisch oder Englisch)
| Title |
PERi-operative Selective Decontamination of the Digestive tract to prevent severe infectious complications after Esophagectomy |
|
Participants (P) |
Patients with primary resectable esophageal carcinoma ((y)cT1-4a N0-3 M0) planned for transthoracic esophagectomy. |
|
Intervention (I) |
The intervention group receives SDD treatment additional to standard care. An oral suspension (10ml) containing amphotericin B (50 mg/ml), colistin sulphate (10 mg/ml), and tobramycin (8 mg/ml). Patients take the oral 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. All other facets of care are equal to the control group. |
|
Control (C) |
Standard care without SDD. |
|
Outcome (O) |
The cumulative incidence of postoperative pneumonia within 30 days after surgery. |
|
Trial Design |
A randomized, controlled, open-label, multicentre trial |
|
Sample Size |
853 participants randomised |
|
Trial duration |
55 months from FPI to CSR |
|
Budget |
2 442 075,17€ of which 1 729 196,88 € in The Netherlands and 712 878,29 € in Belgium |
|
Sponsor |
Radboudumc, Nijmegen,The Netherlands |
|
Chief Investigator |
Prof Dr C Rosman |
|
BCC |
Universitaire Ziekenhuizen Leuven, Belgium |
|
National coordinator |
Dr H Van Veer |
|
Belgian sites |
UZ Leuven, CHU St Luc, CHU Mont Godinne, UZ Antwerpen, AZ Delta Roeselare, CHU Bruxelles Erasme, UZ Gent |
|
Number of participating sites |
Netherlands 12 sites and Belgium 6-7 sites |
Clinicaltrials.gov: tbc
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