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)

Recruiting

Conditions: esophageal cancer

Interventions: Drug: SDD

Registration Number: 2023-504144-33-01

Lead Sponsor: Stichting Radboud University Medical Center

Brief Summary: To evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Detailed Description: Esophagectomy is a complex surgical procedure, associated with significant morbidity and mortality rates. Most postoperative complications are caused by infections (10-30%). These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract, leading to (respiratory) infections. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy that aims to prevent postoperative infections. Pathogenic aerobic gram-negative rods and yeasts tract are reduced, while anaerobic, protective microbiota are preserved. SDD has been shown to lower the risk for respiratory infections in an intensive care setting. Establishing SDD as effective addition to the standard care of esophagectomy patients is expected to increase their chance of survival.

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 853

Inclusion Criteria

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

Exclusion Criteria

Patients planned for rescue surgery
Patients planned for colonic interposition
Known or suspected pregnancy
Patients who have undergone upper GI surgery within 30 days before randomization
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 a known allergy, sensitivity, or interaction to investigational medicinal product
Patients undergoing CVVH
Patients with the inability to swallow the SDD

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SDD treatment	SDD	Standard of care + SDD treatment

Primary Outcome Measures

Name	Time	Method
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)		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)

Secondary Outcome Measures

Name	Time	Method
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		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
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		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
the all-cause mortality within 90 days after surgery		the all-cause mortality within 90 days after surgery
the rate of re-operation within 30 days after surgery		the rate of re-operation within 30 days after surgery
the postoperative length of stay on the intensive care unit (ICU), including re-admissions within 6 months after surgery		the postoperative length of stay on the intensive care unit (ICU), including re-admissions within 6 months after surgery
the postoperative length of the total hospital stay, including re-admissions for any reasons within 6 months after surgery		the postoperative length of the total hospital stay, including re-admissions for any reasons within 6 months after surgery
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)		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)
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		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

Trial Locations

Locations (16): Catharina Ziekenhuis Stichting
🇳🇱
Eindhoven, Netherlands
Zuyderland Medisch Centrum Stichting
🇳🇱
Heerlen, Netherlands
Stichting Radboud University Medical Center
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Nijmegen, Netherlands
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
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Amsterdam, Netherlands
Ziekenhuisgroep Twente Stichting
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Almelo, Netherlands
Leids Universitair Medisch Centrum (LUMC)
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Leiden, Netherlands
Medisch Centrum Leeuwarden B.V.
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Leeuwarden, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱
Groningen, Netherlands
Elisabeth-Tweesteden Ziekenhuis
🇳🇱
Tilburg, Netherlands
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Catharina Ziekenhuis Stichting
🇳🇱Eindhoven, Netherlands
Grard Nieuwenhuijzen
Site contact
+31653166413
grard.nieuwenhuijzen@catharinaziekenhuis.nl