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Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for 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. Sentinel node navigation surgery (SNNS) enables limited lymph node resection, thereby facilitating function-preserving gastrectomy (FPG) and improving quality of life (QoL). SNNS seems to be the promising solution according to previous study, however evidence-based medicine was lacking. It is imperative to establish its safety and efficacy in patients with EGC. However, the optimal implementation of FPG remain unclear. Moreover, objective assessment of postoperative functional outcomes,remains limited.

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 cT1N0M0 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: 2024-02-03
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 312
Treatments
Experimental: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strat
Laparoscopic-endoscopic cooperative surgery (LECS) offers a more targeted approach through the integration of the complementary strengths of endoscopy and laparoscopy. LECS enables accurate targeting, optimal resection margins and tissue sparing excision. Consequently, LECS better preserves gastric architecture and function, potentially leading to enhanced postoperative recovery and QoL. Nevertheless, current evidence supporting LECS for SNNS remains limited.
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
Collaborators: Cancer Hospital Chinese Academy of Medical Scienc, China-Japan Friendship Hospital
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov

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