RATIONALE: Assessment of mediastinal lymph nodes is recommended in patients with non-small cell lung cancer without distant metastases. Linear transesophagealendoscopic ultrasound with real-time guided fine-needle aspiration (EUS-FNA) is a promising, nonsurgical tool for mediastinal staging. OBJECTIVES: We conducted a randomized controlled trial comparing surgical staging with EUS-FNA. METHODS:Patients with proven or suspected non-small cell lung cancer in whom mediastinal exploration was required were randomly assigned to undergo EUS-FNA or the appropriate surgical staging procedure. When EUS-FNA did not show malignant lymph node invasion, a confirmatory surgical staging procedure was done. A negative surgical staging procedure was followed by thoracotomy with systematic lymph node sampling. The primary endpoint was the rate of surgical staging interventions. The secondary endpoints were test performance of EUS-FNA and surgical staging, morbidity, and length of hospital stay, considering surgical staging was performed as an in-patient procedure. MEASUREMENTS AND MAIN RESULTS: A total of 40 patients were randomized: 19 to EUS-FNA, and 21 to surgical mediastinal staging. Patient and tumor characteristics were well balanced between both groups. For patients allocated to EUS-FNA, surgical staging was needed in 32% (P < 0.001). The sensitivity to detect malignant lymph node invasion was 93% (95% confidence interval, 66-99%) for EUS-FNA and 73% (95% confidence interval, 39-93%) for surgical staging (P = 0.29). Complication rate was 0% for EUS-FNA and 5% for surgical staging (P = 1.0). The median hospital stay was significantly shorter for EUS-FNA than for surgical staging (0 vs. 2 nights; P < 0.001). CONCLUSIONS:EUS-FNA reduces the need for surgical staging procedures in patients with (suspected) lung cancer in whom a mediastinal exploration is needed.
RCT Entities:
RATIONALE: Assessment of mediastinal lymph nodes is recommended in patients with non-small cell lung cancer without distant metastases. Linear transesophageal endoscopic ultrasound with real-time guided fine-needle aspiration (EUS-FNA) is a promising, nonsurgical tool for mediastinal staging. OBJECTIVES: We conducted a randomized controlled trial comparing surgical staging with EUS-FNA. METHODS:Patients with proven or suspected non-small cell lung cancer in whom mediastinal exploration was required were randomly assigned to undergo EUS-FNA or the appropriate surgical staging procedure. When EUS-FNA did not show malignant lymph node invasion, a confirmatory surgical staging procedure was done. A negative surgical staging procedure was followed by thoracotomy with systematic lymph node sampling. The primary endpoint was the rate of surgical staging interventions. The secondary endpoints were test performance of EUS-FNA and surgical staging, morbidity, and length of hospital stay, considering surgical staging was performed as an in-patient procedure. MEASUREMENTS AND MAIN RESULTS: A total of 40 patients were randomized: 19 to EUS-FNA, and 21 to surgical mediastinal staging. Patient and tumor characteristics were well balanced between both groups. For patients allocated to EUS-FNA, surgical staging was needed in 32% (P < 0.001). The sensitivity to detect malignant lymph node invasion was 93% (95% confidence interval, 66-99%) for EUS-FNA and 73% (95% confidence interval, 39-93%) for surgical staging (P = 0.29). Complication rate was 0% for EUS-FNA and 5% for surgical staging (P = 1.0). The median hospital stay was significantly shorter for EUS-FNA than for surgical staging (0 vs. 2 nights; P < 0.001). CONCLUSIONS: EUS-FNA reduces the need for surgical staging procedures in patients with (suspected) lung cancer in whom a mediastinal exploration is needed.
Authors: Christian Jenssen; Jouke Tabe Annema; Paul Clementsen; Xin-Wu Cui; Mathias Maximilian Borst; Christoph Frank Dietrich Journal: J Thorac Dis Date: 2015-10 Impact factor: 2.895
Authors: Francys C Verdial; Kathleen S Berfield; Douglas E Wood; Michael S Mulligan; Joshua A Roth; David O Francis; Farhood Farjah Journal: Chest Date: 2019-10-09 Impact factor: 9.410
Authors: Paul De Leyn; Christophe Dooms; Jaroslaw Kuzdzal; Didier Lardinois; Bernward Passlick; Ramon Rami-Porta; Akif Turna; Paul Van Schil; Frederico Venuta; David Waller; Walter Weder; Marcin Zielinski Journal: Transl Lung Cancer Res Date: 2014-08
Authors: Meike M C Hirdes; Matthijs P Schwartz; Kristien M A J Tytgat; Noël J Schlösser; Daisy M D S Sie-Go; Menno A Brink; Bas Oldenburg; Peter D Siersema; Frank P Vleggaar Journal: Surg Endosc Date: 2010-02-23 Impact factor: 4.584