LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial)

Abstract

IntroductionLung cancer was the most common malignancy and the leading cause of cancer-related death in China or worldwide, and surgery is still the preferred treatment for early-stage non-small cell lung cancer (NSCLC). The pattern of lymph node metastasis was found potentially lobe specific, and thus, lobe-specific lymph node dissection (L-SLND) was proposed to be an alternative to systematic lymph node dissection (SLND) for the treatment of early-stage NSCLC.Methods and analysisThe LobE-Specific lymph node diSsectiON trial is a single-institutional, randomised, double-blind and parallel controlled trial to investigate the feasibility of L-SLND in clinically diagnosed stage IA1-2 NSCLC with ground-glass opacity components (≥50%). The intraoperative frozen section examination of surgical tissues confirms the histological type of NSCLC. We hypothesise that L-SLND (experimental group) is not inferior to SLND (control group) and intend to include 672 participants for the experimental group and 672 participants for the control group with a follow-up duration of 60 months. The primary outcomes are 5-year disease-free survival and 5-year overall survival. The secondary outcomes are metastatic lymph node ratio, postoperative complication incidence and mortality, duration of operation, duration of anaesthesia (min), the volume of bleeding (mL) and drainage volume. The intention-to-treat analysis would be performed in the trial.Ethics and disseminationThis trial was approved by the ethics committee on biomedical research, West China Hospital of Sichuan University (2021-332). Informed consent would be obtained from all participants, and dissemination activities would include academic conference presentations and peer-reviewed publications.Trial registration numberThis trial was registered in the Chinese Clinical Trial Registry, ChiCTR2100048415.

Recent Advancements in Minimally Invasive Surgery for Early Stage Non-Small Cell Lung Cancer: A Narrative Review

“…With this, they suggested that lymph node dissection may not be required for pure GGOs and some part-solid GGOs. In contrast to the preceding two reviews, they also acknowledged that considering this excellent prognosis of GGOs, along with the intricacy of conducting RCTs, which demand excessive sampling and follow-up time, RCTs may not be imperative to determine the optimal lymphadenectomy strategy for GGOs, although studies are needed to understand lymphadenectomy for NSCLC in general [ 71 ]. Currently, two ongoing trials are assessing approaches to lymph node removal in GGOs.…”

“…Currently, two ongoing trials are assessing approaches to lymph node removal in GGOs. The LESSON trial is an ongoing, single-institutional, randomized, double-blind, and parallel-controlled trial in China aiming to assess lymph node dissection in clinically diagnosed stage IA NSCLC with GGO components ≥50% (i.e., CTR ≤ 0.5) [ 71 ]. The MELDSIG trial is another ongoing multi-institutional randomized trial in China, analyzing the difference between dissection and sampling in stage Ia NSCLC with GGOs [ 72 ].…”

Clinical Benefits of Lobe-Specific Lymph Node Dissection in Surgery for NSCLC: A Systematic Review and Meta-Analysis

“…In conclusion, LS-LND could be a reasonable surgical strategy compared with S-LND for the treatment of some patients with NSCLC, and its clinical benefits regarding postoperative complications and OS need to be considered. Further RCTs, including a recent study 42 and JCOG 1413, 10 could provide guidance on practicing LS-LND and clarify its impact in more detail.…”

Recent Advancements in Minimally Invasive Surgery for Early-Stage Non-Small Cell Lung Cancer: A Narrative Review

“…Currently, 2 ongoing trials are assessing approaches to lymph node removal in GGOs. The LESSON trial is an ongoing, single-institutional, randomized, double-blind, and parallel-controlled trial in China aiming to assess lymph node dissection in clinically diagnosed stage IA NSCLC with GGO components ≥50% (i.e., CTR ≤ 0.5) [69]. The MELDSIG trial is another ongoing multi-institutional randomized trial in China, analyzing the difference between dissection and sampling in stage Ia NSCLC with GGOs [70].…”