Phase
Condition
Esophageal Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: We will include adult patients (≥18 years of age) with resectable esophageal cancer (adenocarcinoma or squamous cell carcinoma) with high risk for anastomotic leakage (AL) whoprovided informed consent and are scheduled for minimally invasive transthoracic Ivor Lewisesophagectomy. Robotic-assisted procedures will also be included. Patients considered at high risk for AL must have at least one of the following riskfactors:
American Society of Anesthesiologists Classification (ASA) score >2
Diabetes (insulin dependent or HbA1c ≥ 6.5%)
Chronic pulmonary disease (first second of forced expiration (FEV1)/Forced volumevital capacity (FVC) ratio ≤ 70%)
Heart failure (left ventricular ejection fraction (LVEF) <55%)
Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventriculartachyarrhythmia)
Chronic kidney disease stage 4-5 (glomerular filtration rate (GFR) < 30ml/min/1.73 m2)
Chronic liver disease with treated portal hypertension (porto-caval pressure gradient ≥5-≤10mmHg, including patients with transjugular intrahepatic portosystemic shunt (TIPS))
Previous radiotherapy or chemo-radiation ≥50Gray (Gy) (salvage esophagectomy) Alternatively, patients must have at least two of the following risk factors:
Arteriosclerosis score 2 according to van Rossum et al.13 (aorta and coeliac axis)
Malnutrition (Body mass index (BMI) ≤ 18.5kg/m2)
Obesity (BMI ≥ 35kg/m2)
Heart failure with preserved ejection fraction (LVEF >55%)
Active or former smoking
Age > 65 years
World health Organisation (WHO)/Zubrodt score > 1
chronic kidney disease stage 2-3 (GFR 30-89 ml/min/1.73 m2)
chronic liver disease without portal hypertension (porto-caval pressure gradient ≤5mmHg)
Exclusion
Exclusion Criteria:
Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, or dementia.
Patients younger than 18 years
Patients undergoing esophagectomy for benign disease or for malignancy other thanadenocarcinoma or squamous cell carcinoma
Patients scheduled for other technical variants of esophagectomy, such as open,hybrid, or transhiatal procedures (intraoperative conversions to open access surgerywill not be excluded)
Chronic liver disease with portal hypertension (porto-caval pressure gradient >10mmHg)
Distant organ metastasis (cM+)
Study Design
Connect with a study center
University Hospital Zurich
Zürich, 8091
SwitzerlandActive - Recruiting
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