Esophagectomy in Middle and Lower Thoracic Esophageal Cancer Patients Through Left Versus Right T… (NCT02448979) | Clinical Trial Compass
UnknownPhase 3
Esophagectomy in Middle and Lower Thoracic Esophageal Cancer Patients Through Left Versus Right Transthoracic Approach
China800 participantsStarted 2015-01
Plain-language summary
Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical resection remains the most effective method for this malignancy. Although different approaches have been studied for the surgical resection of thoracic esophageal cancer, little evidence has been achieved due to lack of large scale multicenter randomized trials with regard to this issue: whether left transthoracic approach or right transthoracic approach is the optimal surgical approach for treating middle and lower thoracic esophageal cancer without upper mediastinal lymph node metastasis. The purpose of this study is to compare the postoperative local recurrence rate and long-term outcome of esophagectomy through left and right transthoracic approach in the middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients with histologically proved squamous cell esophageal cancer without any previous anti-tumor therapy;
✓. The preoperative clinical TNM stage: cT1b-3N0-1M0;
✓. Adequate function of heart, lung, liver, brain and kidney, which can tolerate esophagectomy either through left or right thoracotomy;
✓. Without any preoperative distant metastases confirmed by preoperative examination such as chest and abdominal CT, brain MRI and bone scan or PET-CT;
✓. No evidence showing suspicious upper mediastinal lymph node metastasis (short diameter of LN \<0.8cm or shortest diameter / longest diameter \<0.65) by the thoracic and abdominal CT and endoscopic ultrasonography(EUS).
✓. Willing to participate the clinical trial and sign informed consent before being enrolled into clinical trail.
Exclusion criteria
✕. Non-squamous cell esophageal carcinoma or has any previous anti-cancer therapy before surgery;
✕. The preoperative clinical TNM stage reaches: N2-3 or M1;