Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer

Phase 2

Completed

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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.

Locations (41): Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸
Orange, California, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸
Savannah, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸
Chicago, Illinois, United States
Boston University Cancer Research Center
🇺🇸
Boston, Massachusetts, United States
Hutchinson Area Health Care
🇺🇸
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸
Litchfield, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸
Minneapolis, Minnesota, United States
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Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States