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

NCT07708012 | Enrolling By Invitation DMC

• 1 other identifier: QYFYEC2026-37
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early-stage Upper Gastrointestinal Cancer; Stomach Cancer, Adenocarcinoma; Laparoscopy-assisted Surgery; Endoscope

Outcome Measures

Primary Outcomes (4)

• Postoperative complications within 30 days after surgery

  Within 30 days after surgery

• Overall survival (OS)

  1 year and 3 years after surgery

• disease-free survival (DFS)

  1 year and 3 years after surgery

• Local recurrence rate (LR)

  1 year and 3 years after surgery

Secondary Outcomes (7)

• Sentinel lymph node prediction accuracy (sensitivity, specificity, etc.)

  Up to two weeks after surgery (confirmed by paraffin pathology)

• Sentinel lymph node tracing success rate

  At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)

• R0 resection rate

  Up to two weeks after surgery(confirmed by paraffin pathology)

• EORTC QLQ-C30/STO22 scale scores（European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30）

  Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery

• Weight and Body Mass Index

  Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after

Study Arms (1)

Perform a combined surgery using both microscopes

EXPERIMENTAL

Procedure: Combined binocular surgery

Interventions

Combined binocular surgery PROCEDURE

1. Inject the fluorescent dye under the endoscope to mark the lesion. 2. Remove the sentinel lymph node area highlighted by fluorescence after 15 minutes. 3. If no lymph node metastasis is found in the sentinel lymph node area (SLNB negative), perform a combined double-scope local gastrectomy (endoscopic combined with laparoscopic local gastrectomy or a modified procedure), completely remove the primary lesion, and ensure negative margins. 4. The local excision specimen should be fully spread and fixed within 20-30 minutes after removal, and sliced continuously at 2 mm intervals. The pathological report needs to include key information such as tissue type, depth of infiltration, margins and vascular invasion. 5. Postoperative patients are managed according to the standard postoperative pathway. Follow-ups are done at 1, 3, 6, 12, 24, and 36 months after surgery, and then annually, including physical exams, tumour marker tests, imaging checks, and quality of life questionnaires.

Perform a combined surgery using both microscopes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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.

Sponsors & Collaborators

• wangdongsheng: lead

Study Sites (1)

Qingdao University Affiliated Hospital West Coast Campus

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Stomach Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-06

Locations

CN (1)