Combined Endoscopic-laparoscopic Sentinel Lymph Node Navigation Surgery in Early Gastric Cancer: a Multicenter Randomized Controlled Trial Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• 3\) Patients without prior gastrointestinal surgery, chemotherapy, or radiotherapy.

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

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

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

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Zheng Zhi, Doctor
zhengzhi@ccmu.edu.cn
+86-010-18311002896
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 312
Treatments
Experimental: Combined endoscopic-laparoscopic sentinel lymph node navigation surgery
Active_comparator: D2 gastrectomy
A preoperative contrast-enhanced abdominal CT scan is conducted to assess the lesion's location, tumor dimensions, and lymph node metastasis (LNM). Preoperative endoscopic dye injection or intraoperative endoscopic localization is utilized to accurately identify the tumor site and ensure adequate resection margins. The extent of lymph node dissection (LND) adheres to the Japanese gastric cancer treatment guidelines 2023 (6th edition)\[4\]. Specifically, D2 distal gastrectomy encompasses lymph nodes No. 1, 3, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, and 12a. D2 proximal gastrectomy includes nodes 1, 2, 3a, 4sa, 4sb, 7, 8a, 9, 11p, and 12a, while D2 total gastrectomy involves nodes 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, and 12a.
Related Therapeutic Areas
Sponsors
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov

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