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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
Sponsorwangdongsheng

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gastroscopy biopsy confirmed a solitary gastric adenocarcinoma;

White light endoscopy, magnifying endoscopy-image-enhanced endoscopy,(ME-IEE), endoscopic ultrasound and enhanced CT comprehensively assessed as cT1N0M0, with no distant metastasis;

Assessed by MDT as unsuitable for simple ESD: including cases beyond the current guideline/consensus recommended ESD curative resection indications, or although at the endoscopic treatment border, significant fibrosis, scarring, non-lifting and other factors make complete endoscopic resection difficult and surgical function-preserving treatment has reasonable benefits;

Lesion maximum diameter in principle ≤5 cm; for lesions close to 5 cm, near the cardia/pylorus or expected to cause stenosis or significant gastric deformation after local resection, they are listed as key review cases before surgery, and gastric preservation path can be directly abandoned during surgery;

Disqualifiers

Preoperative imaging, endoscopy or MDT suggests cT2 or above, definite lymph node metastasis or distant metastasis;

Pregnant or breastfeeding women;

Previous major upper abdominal surgery leading to expected severe adhesions, significantly affecting SLB localisation or surgical implementation;

Recurrent gastric cancer, multiple primary gastric cancers, or those who received preoperative radiotherapy and chemotherapy;

Trial design

Design model

Single group

Treatments tested in this trial

  • Combined double-scope surgery

    Procedure/Surgery

    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.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: Perform a combined surgery using both microscopesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative complications within 30 days after surgery

Time frame
Within 30 days after surgery
2

Overall survival (OS)

Time frame
1 year and 3 years after surgery
3

disease-free survival (DFS)

Time frame
1 year and 3 years after surgery
4

Local recurrence rate (LR)

Time frame
1 year and 3 years after surgery

Secondary outcomes

1

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

Time frame
Up to two weeks after surgery (confirmed by paraffin pathology)
2

Sentinel lymph node tracing success rate

Time frame
At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
3

R0 resection rate

Time frame
Up to two weeks after surgery(confirmed by paraffin pathology)
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

wangdongsheng

Lead sponsor

The Affiliated Hospital of Qingdao University

Sponsor institution