RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.
OBJECTIVES: * Determine the feasibility of performing minimally invasive esophagectomy (MIE), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer. * Determine the complications associated with this procedure in these patients. * Determine the rate at which conversion to open operation is required in patients undergoing this procedure. * Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure. * Determine feasibility and conversion rate of MIE after neoadjuvant therapy. * Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected. * Assess outcomes at follow-up to three years. OUTLINE: This is a multicenter study. Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. ACTUAL ACCRUAL: A total of 110 patients were accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Peri-operative Mortality at 30 Days
The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.
Time frame: Assessed at 30 days from surgery
Rate of Conversion to Open Operation
Proportion of patients who required conversion to operation will be reported.
Time frame: Assessed at surgery
Duration of Operating Time
The length of the operation (total of thoracic and abdominal components) is recorded.
Time frame: Assessed at surgery
Duration of Intensive Care Stay
Number of post-operative days in intensive care is reported.
Time frame: Assessed after surgery until patients are out of intensive care
Overall Length of Hospital Stay
The number of days patients stayed in the hospital after surgery is reported.
Time frame: Assessed after surgery until patients are out of hospital
Total Number of Lymph Nodes Dissected
The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.
Time frame: Assessed at surgery
3-year Survival Rate
Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.
Time frame: Assessed at 3 years
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30-day Peri-operative Mortality After Neoadjuvant Therapy
Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.
Time frame: Assessed at 30 days after surgery
Rate of Conversion to Open Operation After Neoadjuvant Therapy
Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.
Time frame: Assessed at surgery