NCT07835087Recruiting
Image-Guided Platform-Assisted Sentinel Lymph Node Retrieval in Early Gastric Cancer
Image-Guided Platform-Assisted Intraoperative and Postoperative Sentinel Lymph Node Retrieval in Early Gastric Cancer: A Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- 14 Aug 2026
- Primary completion date
- 14 Aug 2027
- Lead sponsor
- Beijing Friendship Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07835087
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 14 Aug 2026 to the primary completion date, 14 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal surgery, chemotherapy, or radiotherapy.
- Concurrent malignancy involving another organ system, or intraoperative confirmation of metastatic gastric cancer or a non-gastric primary malignancy.
Other illness
- Patients who meet the absolute indications for endoscopic submucosal dissection according to the applicable Chinese gastric cancer treatment guidelines.
- Unable to undergo ESD or failure of ESD treatment.
- Contraindications to surgery, including clinically significant coagulation disorders or severe cardiopulmonary dysfunction.
- 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.
Other
- Contraindications to the use of the lymphatic tracer or to endoscopic examination.
- Inability to determine the extent of tracer staining or fluorescence mapping.
- Preoperative imaging indicating bulky, conglomerated, or markedly enlarged metastatic lymph nodes.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.