Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study
OBJECTIVES:
- 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.
Interventional
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
Yes
James D. Luketich, MD
Study Chair
University of Pittsburgh
United States: Federal Government
CDR0000305866
NCT00063986
March 2004
August 2012
Name | Location |
---|---|
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 |