Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Procedure: Minimally invasive esophagectomy (MIE)
- Registration Number
- NCT00063986
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Minimally invasive esophagectomy (MIE) Minimally invasive esophagectomy (MIE) Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
- Primary Outcome Measures
Name Time Method Peri-operative Mortality at 30 Days Assessed at 30 days from surgery The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.
- Secondary Outcome Measures
Name Time Method Total Number of Lymph Nodes Dissected Assessed at surgery The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.
Overall Length of Hospital Stay Assessed after surgery until patients are out of hospital The number of days patients stayed in the hospital after surgery is reported.
3-year Survival Rate Assessed at 3 years Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.
Duration of Operating Time Assessed at surgery The length of the operation (total of thoracic and abdominal components) is recorded.
Duration of Intensive Care Stay Assessed after surgery until patients are out of intensive care Number of post-operative days in intensive care is reported.
Rate of Conversion to Open Operation Assessed at surgery Proportion of patients who required conversion to operation will be reported.
30-day Peri-operative Mortality After Neoadjuvant Therapy Assessed at 30 days after surgery Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.
Rate of Conversion to Open Operation After Neoadjuvant Therapy Assessed at surgery Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.
Trial Locations
- Locations (41)
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Meeker County Memorial Hospital
🇺🇸Litchfield, Minnesota, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States