Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Minimally invasive esophagectomy (MIE)
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: esophageal cancer; minimally invasive esophagectomy (MIE)

Summary:

      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.
    

Eligibility criteria:

        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