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Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512) (SGS2512)

26 avril 2026 mis à jour par: Junfeng Geng, Shanghai Chest Hospital

Effectiveness and Safety of Septum-guided Segmentectomy in Solid-dominant, Deep-seated Early-stage Non-small Cell Lung Cancer (≤2 cm): A Single-center, Prospective, Single-arm Clinical Trial

The purpose of this study is to evaluate the safety and effectiveness of a specialized surgical technique called "Septum-guided Segmentectomy" for treating early-stage lung cancer located deep within the lung tissue.Standard surgery for lung cancer often involves removing an entire lung lobe (lobectomy), which can significantly reduce a patient's breathing capacity. For small tumors, removing only a segment of the lung (segmentectomy) can preserve more healthy tissue. However, for tumors located deep in the lung, traditional segmentectomy is technically challenging and risks leaving cancer cells behind.In this study, surgeons will use the natural anatomical boundaries-the intersegmental veins and their surrounding thin membranes (septa)-as a guide to precisely remove the target lung segment. This "septum-guided" approach aims to ensure the cancer is completely removed while maximizing the preservation of healthy lung function.Participants will be followed for 3 years after surgery to monitor for cancer recurrence and assess their long-term recovery.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a single-center, prospective, single-arm clinical trial (SGS2512) designed to validate the oncological safety and technical feasibility of septum-guided segmentectomy for deep-seated, solid-dominant early-stage non-small cell lung cancer (NSCLC).Background: While segmentectomy has been proven comparable to lobectomy for small peripheral NSCLC (≤2 cm), its application for deep-seated lesions (inner 2/3 of the lung) remains controversial. Traditional methods rely on fixed safety margins, which are often difficult to achieve in deep regions without sacrificing excessive lung tissue. This study utilizes the "intersegmental septum" as a natural barrier to define the resection boundary.Key Procedures:Surgical Technique: All procedures are performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the identification and exposure of the intersegmental veins and the corresponding septa to guide the separation of the target segment.Intraoperative Second Registration: After surgery begins but before the segment is resected, a second check is performed. If frozen section pathology reveals lymph node metastasis or if the anatomical structure is unsuitable for segmentectomy, the procedure will be converted to a standard lobectomy to ensure patient safety.Follow-up: Patients will undergo regular chest CT scans, tumor marker tests, and pulmonary function tests at 1, 6, 12, 18, 24, 30, and 36 months postoperatively.Statistical Design:

The study uses an A'Hern single-stage design to evaluate the primary endpoint. With a null hypothesis (H0) of 3-year RFS ≤ 81% and an alternative hypothesis (H1) of 3-year RFS ≥ 91%, a total of 89 participants are planned for enrollment to ensure 80 evaluable cases. Data analysis will be performed using R software (version 4.0 or above).

Type d'étude

Interventionnel

Inscription (Estimé)

89

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Qing Wang, MD, PhD
  • Numéro de téléphone: +8618516349006
  • E-mail: pillawang@163.com

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200030
        • Recrutement
        • Shanghai Chest Hospital
        • Contact:
        • Contact:
        • Chercheur principal:
          • Junfeng Geng, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Age 18-80 years
  • Clinical stage IA (cT1a-bN0M0)
  • tumor diameter ≤ 2 cm
  • Pathological feature: Solid-dominant lesion (CTR > 0.5)
  • Tumor location: Deep-seated within the lung parenchyma (inner 2/3), defined as the tumor center being located in the inner 2/3 region of the lung field on axial, coronal, and sagittal CT views
  • ECOG Performance Status: 0-1
  • Pulmonary function: FEV1 ≥ 60% predicted and DLCO SB ≥ 60% predicted
  • Participants must be willing and able to provide written informed consent

Exclusion Criteria:

  • Multiple pulmonary nodules or evidence of distant metastasis
  • Intraoperative confirmation of lymph node metastasis (N1/N2) or pleural dissemination
  • History of previous ipsilateral lung surgery
  • History of other malignant tumors within the past 5 years
  • Presence of severe cardiovascular or cerebrovascular diseases that preclude surgical tolerance
  • Pregnancy or breastfeeding

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Septum-guided Segmentectomy
Participants with solid-dominant, deep-seated early-stage NSCLC will undergo septum-guided segmentectomy. The core technique involves identifying and utilizing the intersegmental veins and their surrounding fibrous septa as the anatomical boundaries for precise resection. Systemic lymph node sampling or dissection (at least 3 hilar and 3 mediastinal groups) is mandatory for all patients. An intraoperative second registration will be performed to ensure the oncological appropriateness of the procedure before resection.
Procédure: Septum-guided Segmentectomy
This procedure is performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the precise identification of the intersegmental veins and their surrounding fibrous sheath (septum). These natural anatomical boundaries are utilized to guide the separation and resection of the target lung segment. Unlike traditional methods that rely on fixed safety margins, this approach focuses on anatomical planes to ensure oncological safety for deep-seated lesions. Systematic lymph node sampling or dissection of at least 3 hilar and 3 mediastinal groups is mandatory. An intraoperative second registration is conducted to confirm the nodal status and anatomical suitability before finalizing the resection.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
3-year Recurrence-Free Survival (RFS)
Délai: 3 years post-operation
Percentage of participants who are alive and free of any recurrence (including local, regional, or distant recurrence) at 3 years after the surgery. Recurrence is defined from the date of surgery to the date of first evidence of recurrence by imaging (CT, PET-CT, or MRI) or biopsy.
3 years post-operation

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Operation time
Délai: During surgery (Day 0)
The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
During surgery (Day 0)
Intraoperative Blood Loss
Délai: During surgery (Day 0)
The total volume of blood lost during the surgical procedure, estimated by measuring the volume of suctioned fluid and weighing the surgical sponges.
During surgery (Day 0)
Incidence of Postoperative Complications
Délai: From surgery through 30 days post-operation
The percentage of participants experiencing one or more postoperative complications. Complications will be categorized and graded according to the Clavien-Dindo classification system (focusing on Grade II or higher).
From surgery through 30 days post-operation
Technical Success of Septum-guided Segmentectomy
Délai: During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)
Assessment of the surgical quality, including the R0 resection rate (no microscopic tumor cells at the margin) and the intact exposure rate of intersegmental veins.
During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)
Change in Pulmonary Function (FEV1)
Délai: Pre-operation, 6 months, and 12 months post-operation
Comparison of the Forced Expiratory Volume in 1 second (FEV1) between preoperative baseline and postoperative follow-ups to assess the preservation of lung function.
Pre-operation, 6 months, and 12 months post-operation
Local Recurrence Rate
Délai: Up to 3 years post-operation
Incidence of recurrence occurring at the surgical margin, the remaining ipsilateral lung lobe, or the ipsilateral intrathoracic lymph nodes.
Up to 3 years post-operation

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai Chest Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2026

Achèvement primaire (Estimé)

1 avril 2031

Achèvement de l'étude (Estimé)

1 avril 2031

Dates d'inscription aux études

Première soumission

12 avril 2026

Première soumission répondant aux critères de contrôle qualité

26 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IS26028

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal.

Délai de partage IPD

Beginning 6 months and ending 36 months following article publication.

Critères d'accès au partage IPD

Proposals should be directed to the corresponding author (Junfeng Geng). To gain access, data requestors will need to sign a data access agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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