Esophageal Cancer Clinical Trial
Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
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.
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.
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.)
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
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There are 40 Locations for this study
Orange California, 92868, United States
Savannah Georgia, 31403, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Boston Massachusetts, 02118, United States
Hutchinson Minnesota, 55350, United States
Litchfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55455, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Woodbury Minnesota, 55125, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
New York New York, 10029, United States
Bellefontaine Ohio, 43311, United States
Chillicothe Ohio, 45601, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Lancaster Ohio, 43130, United States
Marietta Ohio, 45750, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Danville Pennsylvania, 17822, United States
Pittsburgh Pennsylvania, 15232, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Dallas Texas, 75230, United States
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