Minimally invasive esophagectomy: Results of a prospective phase II multicenter trial-The eastern cooperative oncology group (E2202) study

James D. Luketich*, Arjun Pennathur, Yoko Franchetti, Paul J. Catalano, Scott Swanson, David J. Sugarbaker, Alberto De Hoyos, Michael A. Maddaus, Ninh T. Nguyen, Al B Benson III, Hiran C. Fernando

*Corresponding author for this work

Research output: Contribution to journalArticle

84 Citations (Scopus)

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. MIEmay 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 underwentMIE 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.

Original languageEnglish (US)
Pages (from-to)702-707
Number of pages6
JournalAnnals of surgery
Volume261
Issue number4
DOIs
StatePublished - Apr 1 2015

Fingerprint

Esophagectomy
Multicenter Studies
Mortality
Esophageal Neoplasms
Length of Stay
Morbidity
Anastomotic Leak
Minimally Invasive Surgical Procedures
Adult Respiratory Distress Syndrome
Atrial Fibrillation
Intensive Care Units
Pneumonia
Prospective Studies
Confidence Intervals
Biopsy
Recurrence
Survival

Keywords

  • Esophageal resection
  • Esophagectomy
  • MIE
  • Minimally invasive
  • Surgical procedures

ASJC Scopus subject areas

  • Surgery

Cite this

Luketich, J. D., Pennathur, A., Franchetti, Y., Catalano, P. J., Swanson, S., Sugarbaker, D. J., ... Fernando, H. C. (2015). Minimally invasive esophagectomy: Results of a prospective phase II multicenter trial-The eastern cooperative oncology group (E2202) study. Annals of surgery, 261(4), 702-707. https://doi.org/10.1097/SLA.0000000000000993
Luketich, James D. ; Pennathur, Arjun ; Franchetti, Yoko ; Catalano, Paul J. ; Swanson, Scott ; Sugarbaker, David J. ; De Hoyos, Alberto ; Maddaus, Michael A. ; Nguyen, Ninh T. ; Benson III, Al B ; Fernando, Hiran C. / Minimally invasive esophagectomy : Results of a prospective phase II multicenter trial-The eastern cooperative oncology group (E2202) study. In: Annals of surgery. 2015 ; Vol. 261, No. 4. pp. 702-707.
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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. MIEmay 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 underwentMIE 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.",
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Luketich, JD, Pennathur, A, Franchetti, Y, Catalano, PJ, Swanson, S, Sugarbaker, DJ, De Hoyos, A, Maddaus, MA, Nguyen, NT, Benson III, AB & Fernando, HC 2015, 'Minimally invasive esophagectomy: Results of a prospective phase II multicenter trial-The eastern cooperative oncology group (E2202) study', Annals of surgery, vol. 261, no. 4, pp. 702-707. https://doi.org/10.1097/SLA.0000000000000993

Minimally invasive esophagectomy : Results of a prospective phase II multicenter trial-The eastern cooperative oncology group (E2202) study. / Luketich, James D.; Pennathur, Arjun; Franchetti, Yoko; Catalano, Paul J.; Swanson, Scott; Sugarbaker, David J.; De Hoyos, Alberto; Maddaus, Michael A.; Nguyen, Ninh T.; Benson III, Al B; Fernando, Hiran C.

In: Annals of surgery, Vol. 261, No. 4, 01.04.2015, p. 702-707.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Minimally invasive esophagectomy

T2 - Results of a prospective phase II multicenter trial-The eastern cooperative oncology group (E2202) study

AU - Luketich, James D.

AU - Pennathur, Arjun

AU - Franchetti, Yoko

AU - Catalano, Paul J.

AU - Swanson, Scott

AU - Sugarbaker, David J.

AU - De Hoyos, Alberto

AU - Maddaus, Michael A.

AU - Nguyen, Ninh T.

AU - Benson III, Al B

AU - Fernando, Hiran C.

PY - 2015/4/1

Y1 - 2015/4/1

N2 - 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. MIEmay 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 underwentMIE 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.

AB - 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. MIEmay 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 underwentMIE 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.

KW - Esophageal resection

KW - Esophagectomy

KW - MIE

KW - Minimally invasive

KW - Surgical procedures

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