NCT00063986

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

Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2004-06-24
• Primary completion: 2010-12-01
• Completion: 2012-08-01
• First posted: 2003-07-09
• Last updated: 2023-06-29
• Results posted: 2013-02-11

Locations

41 sites across 1 country: United States