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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
James D. Luketich, MD
University of Pittsburgh
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Medical City Dallas Hospital||Dallas, Texas 75230|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|Hutchinson Area Health Care||Hutchinson, Minnesota 55350|
|Meeker County Memorial Hospital||Lichfield, Minnesota 55355|
|HealthEast Cancer Care at St. John's Hospital||Maplewood, Minnesota 55109|
|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|
|HealthEast Cancer Care at Woodwinds Health Campus||Woodbury, Minnesota 55125|
|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|
|Mount Carmel Health - West Hospital||Columbus, Ohio 43222|
|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|
|Immanuel Medical Center||Omaha, Nebraska 68122|
|Creighton University Medical Center||Omaha, Nebraska 68131-2197|
|Mercy Medical Center||Springfield, Ohio 45504|
|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|