Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer

Enrolling by invitation · Not applicable

Conditions studied: Early-stage Upper Gastrointestinal Cancer, Stomach Cancer, Adenocarcinoma, Laparoscopy-assisted Surgery, Endoscope

In brief

Gastric cancer is a common malignant tumour worldwide, and in China, the incidence and mortality rates of gastric cancer remain high. Standardised surgical treatment is effective, but the normal structure of the stomach undergoes irreversible changes, leading to a series of adverse reactions. At the same time, some early-stage gastric cancer patients cannot have the lesions completely removed endoscopically, and conventional surgery can affect postoperative normal life. Therefore, laparoscopic and endoscopic cooperative surgery has become a focus for precise stomach-preserving surgery. Participants meeting the surgical criteria are selected, and after discussing the treatment plan with their families and signing informed consent forms, relevant examinations are completed. During surgery, lesions are explored together using laparoscopy and endoscopy, then a fluorescent tracer is injected around the lesion and the lesion boundary is marked. Fifteen minutes after injecting the fluorescent tracer, the illuminated perigastric lymph nodes are the sentinel lymph node region (SLNB), and all fluorescent lymph nodes (sentinel lymph nodes) are removed and sent for intraoperative frozen pathology. If the SLNB is negative: a dual-endoscope combined local gastric resection (endoscope combined with laparoscopic local gastric resection or a modified procedure) is performed to completely remove the lesion, ensuring a negative margin. If the SLNB is positive: immediate conversion to laparoscopic-assisted radical gastrectomy (D2 lymph node dissection) is carried out. For SLNB-negative cases, the dual-endoscope combined local gastric resection specimen is placed in a retrieval bag for full removal and examination, with the stomach wall incision then closed by suturing or using a stapler. Postoperative follow-up includes monitoring tumour outcomes and quality of life.

Key facts

Study ID: NCT07708012
Run by: wangdongsheng
People needed: 30
Starts: 2026-01-01
Expected to finish: 2028-01-01
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18-80, any gender;
Gastric adenocarcinoma confirmed by gastroscopic biopsy, with a single lesion;
Clinical staging cT1N0M0 based on enhanced CT, endoscopic ultrasound and other imaging evaluations (tumour limited to the mucosa or submucosa with no evidence of lymph node or distant metastasis);
Absolute indications for endoscopic submucosal dissection (ESD), with lesions no larger than 5cm, or cases where endoscopic removal is difficult. Absolute indications for ESD (differentiated carcinoma, mucosal T1a stage, without ulcer ≤2 cm or with ulcer ≤3 cm; undifferentiated carcinoma without ulcer ≤2 cm. Difficult cases for endoscopic removal: negative "lifting sign", laterally spreading tumours and scar ulcers etc.);
Meets eCURA score criteria for non-curative ESD requiring additional surgery;
ECOG performance status 0-1;
Patient fully informed and consents, signing the consent form. Note: For inclusion, meeting either criterion ④ or ⑤ is sufficient.

You may not qualify if…

Pregnant or breastfeeding women;
Those with a history of major upper abdominal surgery where severe abdominal adhesions are expected;
Patients with recurrent gastric cancer, multiple primary tumours, or those who have undergone preoperative chemoradiotherapy;
Those meeting ESD indications and having completed curative endoscopic resection according to eCURA standards [12,13];
Patients with other unresectable malignant tumours;
Those with severe heart, lung, liver, or kidney dysfunction who cannot tolerate general anaesthesia and surgery;
Those allergic to indocyanine green (ICG) or nano carbon tracers;
Those with mental illness who cannot cooperate with the study and follow-up.

Where it is running

Qingdao University Affiliated Hospital West Coast Campus — Qingdao, Shandong, China

Full record on ClinicalTrials.gov

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