Laparoscopic and endoscopic dual-scope surgery for early stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a combined double-scope surgical technique to treat solitary cT1N0M0 gastric adenocarcinoma. After preoperative evaluation and informed consent, the lesion is explored with both laparoscopy and endoscopy, and a fluorescent tracer is injected around the lesion to delineate its boundaries. The approach aims to preserve stomach function by avoiding radical gastrectomy when feasible. Eligible patients are those with early-stage tumors assessed as unsuitable for simple endoscopic resection, with tumors up to about 5 cm. The study is conducted at two sites within Qingdao, focusing on patients who meet strict oncologic and functional criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Gastroscopy biopsy confirmed a solitary gastric adenocarcinoma;
2. White light endoscopy, magnifying endoscopy-image-enhanced endoscopy，(ME-IEE）, endoscopic ultrasound and enhanced CT comprehensively assessed as cT1N0M0, with no distant metastasis;
3. 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;
4. 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;
5. ECOG performance status score 0-1, able to tolerate general anaesthesia and laparoscopic surgery;
6. Patient fully understands the potential benefits and uncertainties of SNNS/LECS, the possible false-negative risk of ICG single tracing and intraoperative pathology, as well as the possibility of conversion/additional standard radical gastrectomy, and has signed the informed consent form.

Exclusion Criteria:

1. Preoperative imaging, endoscopy or MDT suggests cT2 or above, definite lymph node metastasis or distant metastasis;
2. Pregnant or breastfeeding women;
3. Previous major upper abdominal surgery leading to expected severe adhesions, significantly affecting SLB localisation or surgical implementation;
4. Recurrent gastric cancer, multiple primary gastric cancers, or those who received preoperative radiotherapy and chemotherapy;
5. Cases that have undergone ESD removal and achieved curative resection according to eCura standards;
6. History of severe ICG allergy or deemed unsuitable by the researcher to use ICG;
7. Patients with other untreated malignant tumours, severe cardiopulmonary dysfunction, or other conditions unable to tolerate general anaesthesia and pneumoperitoneum;
8. Those unable to understand the study process or complete standard follow-up.

Where it's running

• Gastrointestinal Surgery at Qingdao University Affiliated Hospital
  Qingdao, Shandong, China Recruiting
• Qingdao University Affiliated Hospital West Coast Campus
  Qingdao, Shandong, China Enrolling by invitation

Study contacts

• Study coordinator: dongsheng wang Dr wang
• Email: wangdongsheng@qdu.edu.cn
• Phone: +86 18661807896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.