Minimally Invasive Esophagectomy
Minimally Invasive Esophagectomy
Objective The primary aim of this trial was to assess the feasibility of minimally invasive esophagectomy (MIE) in a multi-institutional setting.
Background Esophagectomy is an important, potentially curative treatment for localized esophageal cancer, but is a complex operation. MIE may decrease the morbidity and mortality of resection, and single-institution studies have demonstrated successful outcomes with MIE.
Methods We conducted a multicenter, phase II, prospective, cooperative group study (coordinated by the Eastern Cooperative Oncology Group) to evaluate the feasibility of MIE. Patients with biopsy-proven high-grade dysplasia or esophageal cancer were enrolled at 17 credentialed sites. Protocol surgery consisted of either 3-stage MIE or Ivor Lewis MIE. The primary end point was 30-day mortality. Secondary end points included adverse events, duration of hospital-stay, and 3-year outcomes.
Results Protocol surgery was completed in 95 of the 104 patients eligible for the primary analysis (91.3%). The 30-day mortality in eligible patients who underwent MIE was 2.1%; perioperative mortality in all registered patients eligible for primary analysis was 2.9%. Median intensive care unit and hospital stay were 2 and 9 days, respectively. Grade 3 or higher adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%). At a median follow-up of 35.8 months, the estimated 3-year overall survival was 58.4% (95% confidence interval: 47.7%–67.6%). Locoregional recurrence occurred in only 7 patients (6.7%).
Conclusions This prospective multicenter study demonstrated that MIE is feasible and safe with low perioperative morbidity and mortality and good oncological results. This approach can be adopted by other centers with appropriate expertise in open esophagectomy and minimally invasive surgery.
The incidence of esophageal cancer has been increasing dramatically over the past 3 decades, and esophageal cancer affects more than 450,000 people worldwide. Although squamous cell carcinoma predominates worldwide, in the western world, including the United States, this profound increase has been due to an increase in the incidence of adenocarcinoma of the esophagus. Esophagectomy is an important component of curative treatment for localized esophageal cancer. However, esophageal resection is a complex operation and the mortality of esophageal resection has been significant. In a study from the United States, the mortality of esophagectomy ranged from 8% to 23% and was dependent on hospital volume. The morbidity associated with esophageal resection has also raised concerns about the procedure, and referral for esophagectomy, despite its therapeutic benefit. In an effort to decrease the morbidity associated with esophagectomy, we and others have adopted a minimally invasive approach to esophageal resection.
A minimally invasive approach to esophagectomy was originally described by Cuschieri and DePaula. Since then, minimally invasive esophagectomy (MIE) has been performed with increasing frequency. However, the adoption of MIE has been slow, in part because of the complexity of esophagectomy, even when performed by an open technique, and the relatively small number of esophageal resections that are undertaken in most centers. Ideally, a successful MIE program should perform a sufficient number of esophageal resections per year to maintain expertise in postoperative management as well with the technical aspects of the procedure. In addition, centers should have experience in performing other minimally invasive procedures involving the foregut.
The feasibility of MIE has been previously demonstrated in single-institution studies. Until recently, there were no large, prospective multicenter trials investigating MIE. E2202 is a 2-stage, phase II National Cancer Institute sponsored study that was coordinated by the Eastern Cooperative Oncology Group (ECOG) and also included participation of credentialed surgeons from the Cancer and Leukemia Group B (CALGB) and the American College of Surgeons Oncology Group (ACOSOG). The primary objective of this trial was to evaluate the safety, feasibility, and outcomes following MIE in a multi-institutional setting. This was the first prospective multicenter study of MIE to be undertaken.
Abstract and Introduction
Abstract
Objective The primary aim of this trial was to assess the feasibility of minimally invasive esophagectomy (MIE) in a multi-institutional setting.
Background Esophagectomy is an important, potentially curative treatment for localized esophageal cancer, but is a complex operation. MIE may decrease the morbidity and mortality of resection, and single-institution studies have demonstrated successful outcomes with MIE.
Methods We conducted a multicenter, phase II, prospective, cooperative group study (coordinated by the Eastern Cooperative Oncology Group) to evaluate the feasibility of MIE. Patients with biopsy-proven high-grade dysplasia or esophageal cancer were enrolled at 17 credentialed sites. Protocol surgery consisted of either 3-stage MIE or Ivor Lewis MIE. The primary end point was 30-day mortality. Secondary end points included adverse events, duration of hospital-stay, and 3-year outcomes.
Results Protocol surgery was completed in 95 of the 104 patients eligible for the primary analysis (91.3%). The 30-day mortality in eligible patients who underwent MIE was 2.1%; perioperative mortality in all registered patients eligible for primary analysis was 2.9%. Median intensive care unit and hospital stay were 2 and 9 days, respectively. Grade 3 or higher adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%). At a median follow-up of 35.8 months, the estimated 3-year overall survival was 58.4% (95% confidence interval: 47.7%–67.6%). Locoregional recurrence occurred in only 7 patients (6.7%).
Conclusions This prospective multicenter study demonstrated that MIE is feasible and safe with low perioperative morbidity and mortality and good oncological results. This approach can be adopted by other centers with appropriate expertise in open esophagectomy and minimally invasive surgery.
Introduction
The incidence of esophageal cancer has been increasing dramatically over the past 3 decades, and esophageal cancer affects more than 450,000 people worldwide. Although squamous cell carcinoma predominates worldwide, in the western world, including the United States, this profound increase has been due to an increase in the incidence of adenocarcinoma of the esophagus. Esophagectomy is an important component of curative treatment for localized esophageal cancer. However, esophageal resection is a complex operation and the mortality of esophageal resection has been significant. In a study from the United States, the mortality of esophagectomy ranged from 8% to 23% and was dependent on hospital volume. The morbidity associated with esophageal resection has also raised concerns about the procedure, and referral for esophagectomy, despite its therapeutic benefit. In an effort to decrease the morbidity associated with esophagectomy, we and others have adopted a minimally invasive approach to esophageal resection.
A minimally invasive approach to esophagectomy was originally described by Cuschieri and DePaula. Since then, minimally invasive esophagectomy (MIE) has been performed with increasing frequency. However, the adoption of MIE has been slow, in part because of the complexity of esophagectomy, even when performed by an open technique, and the relatively small number of esophageal resections that are undertaken in most centers. Ideally, a successful MIE program should perform a sufficient number of esophageal resections per year to maintain expertise in postoperative management as well with the technical aspects of the procedure. In addition, centers should have experience in performing other minimally invasive procedures involving the foregut.
The feasibility of MIE has been previously demonstrated in single-institution studies. Until recently, there were no large, prospective multicenter trials investigating MIE. E2202 is a 2-stage, phase II National Cancer Institute sponsored study that was coordinated by the Eastern Cooperative Oncology Group (ECOG) and also included participation of credentialed surgeons from the Cancer and Leukemia Group B (CALGB) and the American College of Surgeons Oncology Group (ACOSOG). The primary objective of this trial was to evaluate the safety, feasibility, and outcomes following MIE in a multi-institutional setting. This was the first prospective multicenter study of MIE to be undertaken.
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