Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512) (SGS2512)
2026년 4월 26일 업데이트: 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.
연구 개요
상태
모병
개입 / 치료
상세 설명
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).
연구 유형
중재적
등록 (추정된)
89
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Junfeng Gen, MD
- 전화번호: +8618017321501
- 이메일: drgengjunfeng@163.com
연구 연락처 백업
- 이름: Qing Wang, MD, PhD
- 전화번호: +8618516349006
- 이메일: pillawang@163.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200030
- 모병
- Shanghai Chest Hospital
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연락하다:
- Qing Wang
- 전화번호: 18516349006
- 이메일: pillawang@163.com
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연락하다:
- Junfeng Geng, MD
- 전화번호: +8618017321501
- 이메일: drgengjunfeng@163.com
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수석 연구원:
- Junfeng Geng, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-year Recurrence-Free Survival (RFS)
기간: 3 years post-operation
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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.
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3 years post-operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Operation time
기간: During surgery (Day 0)
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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
기간: 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
기간: 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
기간: 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)
기간: 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.
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Pre-operation, 6 months, and 12 months post-operation
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Local Recurrence Rate
기간: Up to 3 years post-operation
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Incidence of recurrence occurring at the surgical margin, the remaining ipsilateral lung lobe, or the ipsilateral intrathoracic lymph nodes.
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Up to 3 years post-operation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 4월 1일
기본 완료 (추정된)
2031년 4월 1일
연구 완료 (추정된)
2031년 4월 1일
연구 등록 날짜
최초 제출
2026년 4월 12일
QC 기준을 충족하는 최초 제출
2026년 4월 26일
처음 게시됨 (실제)
2026년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 26일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IS26028
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Beginning 6 months and ending 36 months following article publication.
IPD 공유 액세스 기준
Proposals should be directed to the corresponding author (Junfeng Geng).
To gain access, data requestors will need to sign a data access agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .