Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04162860
Eligibility Criteria:
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) who provided informed consent and are scheduled for minimally invasive transthoracic Ivor Lewis esophagectomy. Robotic-assisted procedures will also be included.
Patients considered at high risk for AL must have at least one of the following risk factors:
* 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 volume vital capacity (FVC) ratio ≤ 70%)
* Heart failure (left ventricular ejection fraction (LVEF) \<55%)
* Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventricular tachyarrhythmia)
* 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 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 than adenocarcinoma or squamous cell carcinoma
* Patients scheduled for other technical variants of esophagectomy, such as open, hybrid, or transhiatal procedures (intraoperative conversions to open access surgery will not be excluded)
* Chronic liver disease with portal hypertension (porto-caval pressure gradient \>10mmHg)
* Distant organ metastasis (cM+)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04162860
Study Brief:
Protocol Section:
NCT04162860