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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



University of Chicago Cancer Research Center Chicago, Illinois  60637
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Meeker County Memorial Hospital Lichfield, Minnesota  55355
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Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
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Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
CCOP - Columbus Columbus, Ohio  43206
Mount Sinai Medical Center New York, New York  10029
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
UPMC Cancer Centers Pittsburgh, Pennsylvania  15232
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Creighton University Medical Center Omaha, Nebraska  68131-2197
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Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Boston University Cancer Research Center Boston, Massachusetts  02118