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:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00937456
Eligibility Criteria:
Inclusion Criteria:
* Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment
* Middle or lower third esophageal carcinoma, junctional tumor Siewert type I
* Patients who underwent or not neoadjuvant chemotherapy or chemoradiation
* Tumor deemed to be resectable in a curative intent at the preoperative setting
* Age less than 75 years old, OMS status 0, 1 or 2
* Patient who can undergo one or the other surgical modality
* Written informed consent form
* Possible follow-up
Exclusion Criteria:
1. General criteria: PO2 ≤ 60 mmHg; PCO2 \> 45 mmHg; FEV ≤ 1000 ml/sec
* Hepatic cirrhosis
* Recent myocardial infarction (in the previous 6 months) or progressive coronary disease
* Distal arteritis (Leriche-Fontaine stage II upwards)
* Concomitant cancer, other than subcarinal esophageal cancer
2. Disease-related factors
* Invasion of subclavicular lymph nodes in a clinical examination or on biospy
* Lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion)
* Recurrent nerve palsy
* Evidence of extension to the tracheobronchial tree
* Signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.)
* Distant metastasis
3. Laparoscopy-related factors
* Patient presenting a general contraindication to laparoscopy
* A history of median or subcostal laparotomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00937456
Study Brief:
Protocol Section:
NCT00937456