Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Minimally invasive esophagectomy (MIE)


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: DISEASE CHARACTERISTICS: High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded). Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy. Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration Stomach must be available for conduit Age of 18 and over ECOG performance status of 0-2 Creatinine less than 2 mg/dL Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed. The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include: Endoscopic ultrasound (EUS) Positron emission tomography (PET) scan and/or laparoscopic staging (Laparoscopic staging could be performed on the day of resection. Additional evaluation was recommended if the PET scan suggested distant metastatic disease.) EXCLUSION CRITERIA: Cancer extending into the stomach more than 20% Prior anti-reflux or gastric operations Prior right thoracotomy Prior major neck operation other than the removal of superficial skin lesion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive esophagectomy (MIE)<br>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. | Procedure: Minimally invasive esophagectomy (MIE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed at 30 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Conversion to Open Operation | Proportion of patients who required conversion to operation will be reported. | Assessed at surgery | 
| Duration of Operating Time | The length of the operation (total of thoracic and abdominal components) is recorded. | Assessed at surgery | 
| Duration of Intensive Care Stay | Number of post-operative days in intensive care is reported. | 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. | 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. | 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. | Assessed at 3 years | 
| 30-day Peri-operative Mortality After Neoadjuvant Therapy | Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported. | 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. | Assessed at surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, minimally invasive esophagectomy (MIE)