Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen
研究概览
简要总结
This prospective, single-center, randomized controlled trial aims to evaluate the clinical effectiveness of an Image-Guided Platform assisted by a deep learning model for sentinel lymph node (SLN) retrieval in patients with early gastric cancer undergoing laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS).
A total of 36 eligible participants will be randomly assigned in a 1:1 ratio to either the Image-Guided Platform group or the Traditional Palpation group. Both groups will undergo standardized indocyanine green fluorescence-guided sentinel lymphatic basin dissection and initial retrieval of fluorescent sentinel lymph nodes. In the experimental group, the remaining sentinel lymphatic basin (SLB) tissue will be examined using the Image-Guided Platform, which integrates radiographic and optical imaging with a deep learning model to identify and localize suspected lymph nodes. In the control group, LN retrieval will be performed using traditional visual inspection and palpation.
The primary objective is to determine whether Image-Guided Platform-assisted LN retrieval increases the total number of SLNs retrieved intraoperatively compared with Traditional Palpation. Secondary objectives include assessment of LN retrieval efficiency, pathological findings, additional LN identification during permanent pathological examination, concordance between intraoperative frozen-section and permanent pathological examination, and other procedural, pathological, technical, and clinical outcomes relevant to the feasibility and performance of the Image-Guided Platform and deep learning model.
详细描述
Sentinel lymph node navigation surgery provides an individualized approach to lymph node assessment in patients with early gastric cancer. However, the identification and retrieval of sentinel lymph nodes (SLNs) from resected sentinel lymphatic basin (SLB) tissue remain largely dependent on visual inspection and manual palpation by experienced physicians. This process can be time-consuming and operator-dependent and may result in missed lymph nodes (LNs), particularly small or visually inconspicuous nodes.
This study is a single-center, prospective, randomized, superiority-controlled trial designed to evaluate an Image-Guided Platform assisted by a deep learning model for intraoperative and postoperative SLN retrieval in patients with early gastric cancer undergoing laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS). Eligible participants will be randomly assigned in a 1:1 ratio to either the Image-Guided Platform group or the Traditional Palpation group. Randomization will be performed using a computer-generated random sequence with allocation concealment.
All participants will undergo a standardized LECS-SNNS procedure. Indocyanine green (ICG) will be injected endoscopically around the gastric lesion for near-infrared fluorescence lymphatic mapping. Fluorescent SLBs will be identified and resected en bloc. Fluorescent SLNs identified by visual inspection and fluorescence imaging will initially be retrieved and designated as SBNs. In the Image-Guided Platform group, the remaining SLB tissue will be placed on the Image-Guided Platform for radiographic and optical imaging. The acquired images will be analyzed using a deep learning model to identify and localize suspected LNs. Physicians will subsequently retrieve suspected LNs according to the image-guided and model-generated localization results. After image-guided LN retrieval, supplementary visual inspection and manual palpation will be performed to identify any additional LNs when appropriate. In the Traditional Palpation group, the remaining SLB tissue will be systematically examined by experienced physicians using standardized dissection, visual inspection, and manual palpation to identify and retrieve suspected LNs without image-guided or deep learning-assisted localization.
All retrieved SLNs will undergo intraoperative frozen-section pathological examination according to standardized institutional procedures. Permanent pathological examination will subsequently be performed to confirm the pathological findings and to identify any additional LNs that were not retrieved during the intraoperative LN retrieval process. This approach will allow assessment of retrieved LNs, additional LNs identified during permanent pathological examination, and the overall LN harvest from the SLB specimen.
Data Collection and Assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will remain unaware of their assigned LN retrieval group. Pathologists responsible for final LN counting, histopathological assessment, and determination of LN metastatic status will be blinded to group allocation. All specimens will be labeled using standardized participant and specimen codes without information indicating group assignment.
Because of the nature of the intervention, personnel operating the Image-Guided Platform and physicians performing LN retrieval cannot be blinded. Statistical analyses will be performed using coded group labels until completion of the prespecified analyses whenever feasible.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years, inclusive.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and considered able to tolerate surgery and anesthesia.
- •Histologically confirmed gastric adenocarcinoma based on preoperative endoscopic biopsy.
- •Clinical stage cT1N0M0 based on multidisciplinary evaluation and appropriate preoperative examinations, including endoscopy and imaging, or patients after non-curative endoscopic submucosal dissection (ESD) who are considered appropriate candidates for further surgical treatment.
- •Adequate hepatic, renal, cardiac, pulmonary, and bone marrow function to tolerate the planned surgical and perioperative management.
- •Considered clinically suitable for laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS).
- •Able to understand the study procedures and provide written informed consent voluntarily.
排除标准
- •Patients who meet the absolute indications for endoscopic submucosal dissection according to the applicable Chinese gastric cancer treatment guidelines.
- •Contraindications to the use of the lymphatic tracer or to endoscopic examination.
- •Unable to undergo ESD or failure of ESD treatment.
- •Inability to determine the extent of tracer staining or fluorescence mapping.
- •Contraindications to surgery, including clinically significant coagulation disorders or severe cardiopulmonary dysfunction.
- •Previous gastrointestinal surgery, chemotherapy, or radiotherapy.
- •Preoperative imaging indicating bulky, conglomerated, or markedly enlarged metastatic lymph nodes.
- •Concurrent malignancy involving another organ system, or intraoperative confirmation of metastatic gastric cancer or a non-gastric primary malignancy.
- •Pregnancy or breastfeeding.
- •Psychiatric disorders, cognitive impairment, or other conditions that impair the ability to provide informed consent or comply with study procedures.
- •Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
研究组 & 干预措施
Image-Guided Platform
Participants in this arm will undergo standardized LECS-SNNS with indocyanine green (ICG) fluorescence mapping. Following initial retrieval of fluorescent SLNs, the remaining SLB tissue will be placed on the Image-Guided Platform for radiographic and optical imaging. The acquired images will be analyzed using a deep learning model to identify and localize suspected LNs. Physicians will subsequently retrieve suspected LNs according to the image-guided and model-generated localization results. Supplementary visual inspection and manual palpation will then be performed when appropriate to identify any additional LNs.
干预措施: Image-Guided Retrieval Specimen Platform (Device)
Traditional Palpation
Participants in this arm will undergo the same standardized LECS-SNNS and ICG fluorescence mapping procedure. Following initial retrieval of fluorescent SLNs, the remaining SLB tissue will be systematically examined by experienced physicians using standardized dissection, visual inspection, and manual palpation to identify and retrieve suspected LNs without image-guided or deep learning-assisted localization.
干预措施: Traditional Palpation-Based Sentinel Lymph Node Retrieval (Procedure)
结局指标
主要结局
Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen
时间窗: During the operation, before completion of intraoperative frozen-section pathological assessment
The primary outcome is the per-participant total number of SLNs retrieved from the resected SLB specimen and submitted for intraoperative frozen-section pathological examination. The total number is defined as the sum of fluorescent SLNs identified during initial fluorescence-guided retrieval (SBNs) and additional non-fluorescent LNs retrieved from the residual SLB tissue during subsequent LN retrieval (BNs). The total number of intraoperatively retrieved SLNs will be compared between the Image-Guided Platform group and the Traditional Palpation group.
次要结局
- Number of Fluorescent Specimens Not Pathologically Confirmed as Lymph Nodes(From the operation through completion of permanent pathological examination, within 30 days after surgery)
- Number of Occult Lymph Nodes Identified During Permanent Pathological Examination(From the operation through completion of permanent pathological examination, within 30 days after surgery)
- Total Lymph Node Harvest From the Sentinel Lymphatic Basin Specimen(From the operation through completion of permanent pathological examination, within 30 days after surgery)
- Proportion of Participants With Occult Lymph Nodes Identified During Permanent Pathological Examination(From the operation through completion of permanent pathological examination, within 30 days after surgery)
- Lymph Node-Level Concordance Rate Between Intraoperative Frozen-Section and Permanent Pathological Examination(From the operation through completion of permanent pathological examination, within 30 days after surgery)
- Lymph Node Retrieval Time(During LN retrieval on the day of surgery)
- Intraoperative Sentinel Lymph Node Retrieval and Frozen-Section Pathology Workflow Time(During the operation on the day of surgery)
- Number of Additional Lymph Nodes Retrieved by Supplementary Manual Palpation After Image-Guided Retrieval(During LN retrieval on the day of surgery)
- Number of Lymph Nodes Retrieved With the Image-Guided Platform(During LN retrieval on the day of surgery)
- Pathological Confirmation Rate of Suspected Lymph Nodes Retrieved From Residual Sentinel Lymphatic Basin Tissue(From LN retrieval through completion of permanent pathological examination, within 30 days after surgery)
- Lymph Node Detection Rate of the Image-Guided Platform(From specimen imaging through completion of permanent pathological examination, within 30 days after surgery)
研究者
JunZhang
Chief Surgeon
Beijing Friendship Hospital