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Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study


- 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.

Inclusion Criteria



- 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

- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Peri-operative Mortality at 30 Days

Outcome Description:

The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.

Outcome Time Frame:

Assessed at 30 days from surgery

Safety Issue:


Principal Investigator

James D. Luketich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

August 2012

Related Keywords:

  • Esophageal Cancer
  • esophageal cancer
  • minimally invasive esophagectomy (MIE)
  • Esophageal Diseases
  • Esophageal Neoplasms



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