Combined Endoscopic-laparoscopic Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer

Not Applicable

Recruiting

• Conditions: Early Gastric Cancer

• Registration Number: NCT06788548
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

The main treatment for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications and noncurative resection of ESD remains unestablished. Combined endoscopic-laparoscopic sentinel node navigation surgery seems to be the promising solution according to previous study, however evidence-based medicine in China was lacking. It is imperative to establish its safety and efficacy in Chinese patients with EGC.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-20
• Study First Submitted: 2024-12-16
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Primary Completion: 2029-11-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• 1. Patients aged 18-80 years, regardless of gender. 2) Patients with Eastern Cooperative Oncology Group (ECOG) score ≤ 2 and American Society of Anesthesiologists (ASA) score ≤ 2 who are candidates for a curative D2 gastrectomy.

  2. Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.

  3. Patients with normal liver, kidney, heart, lung, and bone marrow function (GPT × 109 /L, PLT>109 /L).

  4. Patients capable of understanding and adhering to the research protocol. 6) Patients who can provide written informed consent, either personally or through legal representative.

  5. Patients with cT1NxM0 gastric cancer or after non-curative ESD resection, according to the UICC TNM staging system, 8th edition.

Exclusion Criteria

• 1. Patients with a contraindication for gastroscopy. 2) Patients with uncontrollable diseases, such as coagulation disorders, epilepsy, central nervous system diseases or mental disorders, cardiopulmonary insufficiency, unstable angina, myocardial infarction, a cerebrovascular accident that occurred within 6 months, and other surgical contraindications.

  2. Patients unable to undergo general anesthesia or surgical treatment due to conditions related to other organs, or unwilling to undergo surgery.

  3. Patients with gastric stump cancer, recurrent gastric cancer, multiple primary malignant tumors in the abdominopelvic cavity, or a history of other malignant tumors within the previous 5 years.

  4. Pregnant or lactating women. 6) Participants enrolled in other clinical trials. 7) Patients with undeterminable tracer staining range or contraindications to tracer use.

  5. Patients who fail to receive or fail ESD therapy. 9) Patients who meet the absolute indication of ESD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5-year overall recurrence rate.	From treatment to 5-years after surgery

Secondary Outcome Measures

Name	Time	Method
5-year overall survival	From treatment to 5-years after surgery
Mortality (within 30 days after surgery)；Unscheduled second surgery (within 30 days after surgery) and Unplanned return to hospital (within 30 days after surgery)	From treatment to 30-days after surgery
rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine；Rates of remedial and additional surgery	From enrollment to 1 week after surgery
Perioperative complication rate (within 30 days after surgery, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula	From treatment to 30-days after surgery	According to the Clavien-Dindo scale, if the postoperative complication grade is higher than grade II, it is considered clinically significant)
Operation time	From treatment to 1 week after surgery
R0 resection rate	From treatment to 1 week after surgery
additional surgical operation rate	From treatment to 5-years after surgery
blood loss	From treatment to 30-days after surgery
postoperative length of stay	From treatment to 30-days after surgery
overall hospitalization cost	From treatment to 5-years after surgery
Gastric emptying scintigraphy result	From treatment to 5-years after surgery
date of gas evacuation	From treatment to 30-days after surgery

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China