Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512) (SGS2512)
2026年4月26日 更新者：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.
調査の概要
状態
募集
詳細な説明
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).
研究の種類
介入
入学 (推定)
89
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Junfeng Gen, MD
- 電話番号：+8618017321501
- メール：drgengjunfeng@163.com
研究連絡先のバックアップ
- 名前：Qing Wang, MD, PhD
- 電話番号：+8618516349006
- メール：pillawang@163.com
研究場所
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- 募集
- Shanghai Chest Hospital
-
コンタクト：
- Qing Wang
- 電話番号：18516349006
- メール：pillawang@163.com
-
コンタクト：
- Junfeng Geng, MD
- 電話番号：+8618017321501
- メール：drgengjunfeng@163.com
-
主任研究者：
- Junfeng Geng, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
3-year Recurrence-Free Survival (RFS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Operation time
時間枠：During surgery (Day 0)
|
The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
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During surgery (Day 0)
|
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Intraoperative Blood Loss
時間枠：During surgery (Day 0)
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The total volume of blood lost during the surgical procedure, estimated by measuring the volume of suctioned fluid and weighing the surgical sponges.
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During surgery (Day 0)
|
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Incidence of Postoperative Complications
時間枠：From surgery through 30 days post-operation
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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).
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From surgery through 30 days post-operation
|
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Technical Success of Septum-guided Segmentectomy
時間枠：During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)
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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.
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During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)
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Change in Pulmonary Function (FEV1)
時間枠：Pre-operation, 6 months, and 12 months post-operation
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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
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Local Recurrence Rate
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
- Tsubokawa N, Mimae T, Saeki A, Miyata Y, Kanno C, Kudo Y, Nagashima T, Ito H, Ikeda N, Okada M. Feasibility and comparative prognosis of segmentectomy versus lobectomy in centrally located small and solid dominant cN0 non-small cell lung cancer. J Thorac Cardiovasc Surg. 2025 Feb;169(2):427-435.e2. doi: 10.1016/j.jtcvs.2024.06.016. Epub 2024 Jul 3.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月1日
一次修了 (推定)
2031年4月1日
研究の完了 (推定)
2031年4月1日
試験登録日
最初に提出
2026年4月12日
QC基準を満たした最初の提出物
2026年4月26日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月4日
QC基準を満たした最後の更新が送信されました
2026年4月26日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IS26028
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
IPD 共有時間枠
Beginning 6 months and ending 36 months following article publication.
IPD 共有アクセス基準
Proposals should be directed to the corresponding author (Junfeng Geng).
To gain access, data requestors will need to sign a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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