Colistin sulfate; Tobramycin for Esophageal cancer

Inclusion criteria

• {"criterion_text":"-\tDiagnosis 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\n- Age ≥ 18 years\n-\tAble to give written informed consent"}

Exclusion criteria

• {"criterion_text":"-\tPatients planned for rescue surgery\n-\tPatients planned for colonic interposition\n-\tKnown or suspected pregnancy\n-\tPatients who have undergone upper GI surgery within 30 days before randomization\n-\tUnable to understand the study information, study instructions and give informed consent\n-\tPatients enrolled in a trial that would interact with the intervention\n-\tPatients with a known allergy, sensitivity, or interaction to investigational medicinal product\n-\tPatients undergoing CVVH\n-\tPatients with the inability to swallow the SDD"}

Primary endpoints

• {"endpoint_text":"-the cumulative incidence of postoperative pneumonia within 30 days after surgery. (Pneumonia will be defined by the following criteria: - Positive sputum culture OR - Presence of a new progressive radiographic infiltrate plus at least 2 of the following clinical features: - Fever > 38.5°C - Leukocytosis (>11.0) or leukopenia (<4.0) - Purulent secretions)","definition_or_measurement_approach":"Pneumonia defined as: Positive sputum culture OR presence of a new progressive radiographic infiltrate plus at least 2 of the following clinical features: Fever > 38.5°C; Leukocytosis (>11.0) or leukopenia (<4.0); Purulent secretions. Measured as cumulative incidence within 30 days after surgery."}

Secondary endpoints

• {"endpoint_text":"-the cumulative incidence of all postoperative infectious complications within 30 days as registered in DUCA (postoperative pneumonia, Clostridium difficile infection, urinary tract infection, wound infection/abscess requiring wound opening or antibiotic treatment, central line infection requiring line removal or antibiotic treatment, intra-thoracic/intra-abdominal abscess, generalised sepsis as defined by Evans, Rhodes (30), other infections requiring antibiotics","definition_or_measurement_approach":"Cumulative incidence within 30 days postoperatively as registered in DUCA (database) of the listed infectious complications."}
• {"endpoint_text":"-the cumulative incidence of anastomotic leakage within 30 days after esophagectomy for which endoscopic, radiologic, or surgical re-intervention is needed. This corresponds to the definition of the ECCG of anastomotic leakage type II and III Low, Alderson (32). Anastomotic leakage is defined by contrast leakage on CT-scan with intravenous and oral contrast (swallow CT-scan) upon clinical suspicion, by endoscopy or by drainage of ingested materials into the chest tube (thoracic anastomoses) or in","definition_or_measurement_approach":"Cumulative incidence within 30 days of anastomotic leakage requiring endoscopic, radiologic, or surgical re-intervention; defined per ECCG type II/III criteria and by contrast leakage on swallow CT, endoscopy, or drainage of ingested materials into chest tube."}
• {"endpoint_text":"-the all-cause mortality within 90 days after surgery","definition_or_measurement_approach":"All-cause mortality measured as cumulative deaths within 90 days after surgery."}
• {"endpoint_text":"-the rate of re-operation within 30 days after surgery","definition_or_measurement_approach":"Rate (incidence) of re-operation occurrences within 30 days post-surgery."}
• {"endpoint_text":"-the postoperative length of stay on the intensive care unit (ICU), including re-admissions within 6 months after surgery","definition_or_measurement_approach":"Postoperative ICU length of stay measured including any ICU readmissions within 6 months after surgery."}
• {"endpoint_text":"-the postoperative length of the total hospital stay, including re-admissions for any reasons within 6 months after surgery","definition_or_measurement_approach":"Total postoperative hospital length of stay measured including any readmissions for any reason within 6 months after surgery."}
• {"endpoint_text":"-the quality of life (QoL) after 30 days, 3 months and 6 months after surgery (using internationally validated EORTC OG25, QLQC30 and EuroQoL-5D-5L questionnaires)","definition_or_measurement_approach":"QoL assessed at 30 days, 3 months and 6 months post-surgery using validated instruments EORTC OG25, QLQ-C30 and EuroQol-5D-5L."}
• {"endpoint_text":"-Direct and indirect costs. The in-hospital and societal costs up to 6 months after surgery will be estimated with the help of the medical consumption questionnaire and the productivity cost questionnaire, developed by the iMTA","definition_or_measurement_approach":"Direct and indirect costs up to 6 months post-surgery estimated using the medical consumption questionnaire and the iMTA productivity cost questionnaire."}

Netherlands

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

04-09-2025

Processing Time Days

560

Number Of Sites

10

Number Of Participants

553

Belgium

Earliest CTIS Part Ii Submission Date

13-03-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

541

Number Of Sites

6

Number Of Participants

300

Primary sponsor

Full Name

Stichting Radboud University Medical Center

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"ZonMw","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"KCE","duties_or_roles":"Source of monetary support","organisation_type":""}