Early Gastric CancerNCT07835087
Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer
A study testing Image-Guided Retrieval Specimen Platform and Traditional Palpation-Based Sentinel Lymph Node Retrieval in people with Early Gastric Cancer and Gastric Adenocarcinoma, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenocarcinoma
- What is being tested?
- Image-Guided Retrieval Specimen Platform and Traditional Palpation-Based Sentinel Lymph Node Retrieval
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2026to 14 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Zhi Zheng, MD, +86-010-18311002896, zhengzhi@ccmu.edu.cn
About this study
Official title: Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial
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.
Read the detailed description
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
Study data will include a broad range of demographic, clinical, diagnostic, surgical, pathological, technical, imaging-related, and perioperative information relevant to early gastric cancer, sentinel lymph node navigation surgery, LN retrieval, and pathological assessment. Data collection may include baseline demographic and clinical characteristics; medical and treatment history; preoperative laboratory, endoscopic, imaging, and clinical staging information; tumor-related characteristics; intraoperative and surgical variables; fluorescence mapping and SLB characteristics; LN retrieval and specimen-handling information; Image-Guided Platform-related parameters; radiographic and optical image-related parameters; deep learning model-related parameters; intraoperative frozen-section findings; permanent pathological findings; LN-related characteristics; perioperative recovery and safety information; and other clinically relevant variables collected according to the study protocol and case report forms. Derived variables, composite variables, subgroup classifications, technical performance measures, image- or specimen-level parameters, and exploratory clinical or pathological variables may also be generated from the collected data according to prespecified or exploratory statistical analyses. The collected information will be used to compare the effectiveness, efficiency, and diagnostic performance of Image-Guided Platform-assisted LN retrieval and Traditional Palpation, and to explore factors potentially associated with LN retrieval, total LN harvest, pathological assessment, technical performance, and other relevant clinical outcomes.
- Conditions
- Early Gastric Cancer, Gastric Adenocarcinoma
- Being tested
- Image-Guided Retrieval Specimen Platform, Traditional Palpation-Based Sentinel Lymph Node Retrieval
- Keywords
- Sentinel lymph node, Sentinel lymphatic basin, Sentinel lymph node navigation surgery, Laparoscopic-endoscopic cooperative surgery, Artificial intelligence, Deep learning, Indocyanine green, Fluorescence navigation, Lymph node retrieval, Pathological examination, Specimen processing, Early gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided Retrieval Specimen PlatformDevice
The Image-Guided Retrieval Specimen Platform is an ex vivo LN retrieval system integrating radiographic imaging, optical imaging, and deep learning-based image analysis. Resected SLB tissue is placed on the platform for image acquisition. The acquired images are analyzed using a deep learning model to identify and localize regions suspected of containing LNs. Physicians subsequently retrieve suspected LNs according to the image-guided and model-generated localization results. All retrieved specimens are submitted for standardized pathological examination.
Traditional Palpation-Based Sentinel Lymph Node RetrievalProcedure or surgery
The residual SLB tissue will be systematically examined by experienced physicians using standardized dissection, visual inspection, and manual palpation to identify and retrieve suspected LNs. No Image-Guided Platform or deep learning-assisted localization will be used.
| Study group | Role | What they receive |
|---|---|---|
| Image-Guided Platform | Experimental | 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. Receives: Device: Image-Guided Retrieval Specimen Platform |
| Traditional Palpation | Active comparator | 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. Receives: Procedure: Traditional Palpation-Based Sentinel Lymph Node Retrieval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen
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.
Measured: During the operation, before completion of intraoperative frozen-section pathological assessment
Secondary outcomes (11)
Number of Fluorescent Specimens Not Pathologically Confirmed as Lymph Nodes
The number of ICG-fluorescent specimens initially retrieved as fluorescent SLNs but not subsequently confirmed as actual LNs by pathological examination will be recorded for each participant and compared between the two groups.
Measured: From the operation through completion of permanent pathological examination, within 30 days after surgery
Number of Occult Lymph Nodes Identified During Permanent Pathological Examination
The number of additional LNs identified during permanent pathological examination of the residual SLB tissue after completion of intraoperative LN retrieval will be recorded for each participant. These LNs correspond to occult lymph nodes (OBNs) that were not identified during intraoperative LN retrieval.
Measured: From the operation through completion of permanent pathological examination, within 30 days after surgery
Total Lymph Node Harvest From the Sentinel Lymphatic Basin Specimen
The total LN harvest from the resected SLB specimen will be recorded for each participant. Total LN harvest is defined as the sum of LNs retrieved during intraoperative LN retrieval and additional LNs identified during permanent pathological examination.
Measured: 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
The proportion of participants in whom at least one occult LN is identified during permanent pathological examination after completion of intraoperative LN retrieval will be assessed.
Measured: 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
For SLNs examined by both methods, the concordance rate will be calculated as the number of SLNs with concordant pathological classifications between intraoperative frozen-section and permanent pathological examination divided by the total number of SLNs examined by both methods, expressed as a percentage.
Measured: From the operation through completion of permanent pathological examination, within 30 days after surgery
Lymph Node Retrieval Time
The time required to complete LN retrieval from the residual SLB tissue will be recorded for each participant and reported in minutes.
Measured: During LN retrieval on the day of surgery
Intraoperative Sentinel Lymph Node Retrieval and Frozen-Section Pathology Workflow Time
The total workflow time will be recorded for each participant. Timing will begin when the residual SLB tissue, following initial retrieval of fluorescent SLNs, is transferred for further LN retrieval and pathological processing and will end when the intraoperative frozen-section pathology report is issued. The outcome will be reported in minutes.
Measured: During the operation on the day of surgery
Number of Additional Lymph Nodes Retrieved by Supplementary Manual Palpation After Image-Guided Retrieval
In the Image-Guided Platform group, the number of additional LNs retrieved by supplementary visual inspection and manual palpation after completion of image-guided LN retrieval will be recorded. This outcome reflects LNs that were not initially identified during image-guided retrieval but were subsequently detected by supplementary manual palpation.
Measured: During LN retrieval on the day of surgery
Number of Lymph Nodes Retrieved With the Image-Guided Platform
In the Image-Guided Platform group, the number of suspected LNs identified using the platform and subsequently retrieved for pathological examination will be recorded.
Measured: During LN retrieval on the day of surgery
Pathological Confirmation Rate of Suspected Lymph Nodes Retrieved From Residual Sentinel Lymphatic Basin Tissue
The pathological confirmation rate will be assessed separately according to the LN retrieval method used for the residual SLB tissue after initial fluorescent SLN retrieval. For each retrieval method, the pathological confirmation rate will be calculated as the number of retrieved specimens pathologically confirmed as actual LNs divided by the total number of specimens retrieved as suspected LNs, expressed as a percentage.
Measured: From LN retrieval through completion of permanent pathological examination, within 30 days after surgery
Lymph Node Detection Rate of the Image-Guided Platform
The LN detection rate of the Image-Guided Platform will be calculated as the number of pathologically confirmed actual LNs correctly identified by the Image-Guided Platform divided by the total number of actual LNs ultimately identified from the residual SLB tissue examined by the platform, expressed as a percentage. The denominator will include pathologically confirmed LNs retrieved with the Image-Guided Platform, additional LNs retrieved by supplementary manual palpation, and additional LNs subsequently identified during permanent pathological examination of the residual SLB tissue.
Measured: From specimen imaging through completion of permanent pathological examination, within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start14 Aug 2026
- Primary completion14 Aug 2027 (estimated)
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 the same standardized laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS) and initial fluorescence-guided sentinel lymph node (SLN) retrieval. The randomized intervention applies to subsequent lymph node (LN) retrieval from the residual sentinel lymphatic basin (SLB) tissue.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JunZhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835087
- Sponsor's protocol ID
- 2026-P2-489-01
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07835087
- Acronym / sponsor ID
- 2026-P2-489-01
- Conditions
- Early Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- Sentinel lymph node, Sentinel lymphatic basin, Sentinel lymph node navigation surgery, Laparoscopic-endoscopic cooperative surgery, Artificial intelligence, Deep learning, Indocyanine green, Fluorescence navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 14 Aug 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study data will include a broad range of demographic, clinical, diagnostic, surgical, pathological, technical, imaging-related, and perioperative information relevant to early gastric cancer, sentinel lymph node navigation surgery, LN retrieval, and pathological assessment. Data collection may include baseline demographic and clinical characteristics; medical and treatment history; preoperative laboratory, endoscopic, imaging, and clinical staging information; tumor-related characteristics; intraoperative and surgical variables; fluorescence mapping and SLB characteristics; LN retrieval and specimen-handling information; Image-Guided Platform-related parameters; radiographic and optical image-related parameters; deep learning model-related parameters; intraoperative frozen-section findings; permanent pathological findings; LN-related characteristics; perioperative recovery and safety information; and other clinically relevant variables collected according to the study protocol and case report forms. Derived variables, composite variables, subgroup classifications, technical performance measures, image- or specimen-level parameters, and exploratory clinical or pathological variables may also be generated from the collected data according to prespecified or exploratory statistical analyses. The collected information will be used to compare the effectiveness, efficiency, and diagnostic performance of Image-Guided Platform-assisted LN retrieval and Traditional Palpation, and to explore factors potentially associated with LN retrieval, total LN harvest, pathological assessment, technical performance, and other relevant clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 the same standardized laparoscopic-endoscopic cooperative surgery combined with sentinel lymph node navigation surgery (LECS-SNNS) and initial fluorescence-guided sentinel lymph node (SLN) retrieval. The randomized intervention applies to subsequent lymph node (LN) retrieval from the residual sentinel lymphatic basin (SLB) tissue.
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Platform | Experimental | Device: Image-Guided Retrieval Specimen PlatformParticipants 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. |
| Traditional Palpation | Active comparator | Procedure: Traditional Palpation-Based Sentinel Lymph Node RetrievalParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-Guided Retrieval Specimen PlatformThe Image-Guided Retrieval Specimen Platform is an ex vivo LN retrieval system integrating radiographic imaging, optical imaging, and deep learning-based image analysis. Resected SLB tissue is placed on the platform for image acquisition. The acquired images are analyzed using a deep learning model to identify and localize regions suspected of containing LNs. Physicians subsequently retrieve suspected LNs according to the image-guided and model-generated localization results. All retrieved specimens are submitted for standardized pathological examination. | Device | Image-Guided Platform |
| Traditional Palpation-Based Sentinel Lymph Node RetrievalThe residual SLB tissue will be systematically examined by experienced physicians using standardized dissection, visual inspection, and manual palpation to identify and retrieve suspected LNs. No Image-Guided Platform or deep learning-assisted localization will be used. | Procedure or surgery | Traditional Palpation |
Primary outcome
Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen
Time frame: 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.
11 secondary outcomes
Number of Fluorescent Specimens Not Pathologically Confirmed as Lymph Nodes
Time frame: From the operation through completion of permanent pathological examination, within 30 days after surgery
Number of Occult Lymph Nodes Identified During Permanent Pathological Examination
Time frame: From the operation through completion of permanent pathological examination, within 30 days after surgery
Total Lymph Node Harvest From the Sentinel Lymphatic Basin Specimen
Time frame: 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
Time frame: 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
Time frame: From the operation through completion of permanent pathological examination, within 30 days after surgery
Lymph Node Retrieval Time
Time frame: During LN retrieval on the day of surgery
Intraoperative Sentinel Lymph Node Retrieval and Frozen-Section Pathology Workflow Time
Time frame: During the operation on the day of surgery
Number of Additional Lymph Nodes Retrieved by Supplementary Manual Palpation After Image-Guided Retrieval
Time frame: During LN retrieval on the day of surgery
Number of Lymph Nodes Retrieved With the Image-Guided Platform
Time frame: During LN retrieval on the day of surgery
Pathological Confirmation Rate of Suspected Lymph Nodes Retrieved From Residual Sentinel Lymphatic Basin Tissue
Time frame: From LN retrieval through completion of permanent pathological examination, within 30 days after surgery
Lymph Node Detection Rate of the Image-Guided Platform
Time frame: From specimen imaging through completion of permanent pathological examination, within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-Guided Retrieval Specimen Platform and Traditional Palpation-Based Sentinel Lymph Node Retrieval in people with Early Gastric Cancer and Gastric Adenocarcinoma, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi Zheng, MD (+86-18311002896, zhengzhi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Sentinel Lymph Nodes Retrieved Intraoperatively From the Sentinel Lymphatic Basin Specimen (time frame: During the operation, before completion of intraoperative frozen-section pathological assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.