Summary (Dutch or French)
Every day, 7 people in the Netherlands and 4 people in Belgium are told that they have cancer of the food pipe (esophageal cancer).
Patients with cancer of the food pipe - between the mouth and stomach – often have to undergo complex surgery to remove and reconstruct (parts of) it. Despite standardization in surgical techniques, recovery after the operation is often complicated and quality of life is diminished. One important source of complications are microorganisms in the throat, food pipe and stomach that cause infections and inflammations at the level of the join and in the lungs. The removal of these infectious microorganisms before the surgery and during recovery might be important for improving and sometimes, saving these patients’ lives. Such a targeted approach is the so-called Selective Decontamination of the Digestive tract (SDD), which is based on the preventive intake of selected antibiotics before the surgery takes place as to decrease the presence of microorganisms in the throat and food pipe.
Importantly, there is some evidence suggesting, that this strategy can reduce up to 50% of infections after the operation. Nevertheless, reliable evidence in the field of removal of the food pipe is not available and as such research to create this evidence is still warranted. We want to set up the first large-scale trial to deliver the evidence needed to use SDD in standard clinical care of all patients undergoing surgery for cancer of the food pipe.
| 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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