Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b）

Официальное название

Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery
  Patients without prior ESD received ESD with laparoscopic sentinel basin dissection (LSBD) for ESD resectable lesions, otherwise patients received laparoscopic-endoscopic cooperative regional gastrectomy (LRG) with LSBD. For patients with prior non-curative ESD, LSBD alone was performed if margins were negative, otherwise LRG with LSBD was conducted. Intraoperative frozen-section pathological examination of the horizontal resection margin of the ESD or full-thickness specimen. During laparoscop
• Процедура Laparoscopic D2 radical gastrectomy
  Preparation: The patient is positioned supine with general anesthesia. An orogastric tube and Foley catheter are inserted. Antibiotics are administered, and sequential stockings are applied. Port Placement: Pneumoperitoneum is created via a Veress needle at the umbilicus. Working ports are placed in the upper quadrants, with a fifth port for liver retraction. Abdominal Exploration: The abdomen is inspected for metastases, and peritoneal cytology is performed. Dissection and Lymph Node Removal: T

Первичные конечные точки

• 3 and 5-year disease free survival [Срок оценки: From treatment to 3 and 5-years after surgery]

Вторичные конечные точки (12)

• 5-year overall survival [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From treatment to 30-days after surgery]
• Operation time [Срок оценки: From treatment to 1 week after surgery]
• R0 resection rate [Срок оценки: From treatment to 1 week after surgery]
• additional surgical operation rate [Срок оценки: From treatment to 5-years after surgery]
• blood loss [Срок оценки: From treatment to 30-days after surgery]
• postoperative length of stay [Срок оценки: From treatment to 30-days after surgery]
• overall hospitalization cost [Срок оценки: From treatment to 5-years after surgery]
• Gastric emptying scintigraphy result [Срок оценки: From treatment to 5-years after surgery]
• date of gas evacuation [Срок оценки: From treatment to 30-days after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

4\) 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.

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

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Friendship Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06788548 · BRWEP2024W162020112 · 7232334 · D171100006517003 · PX2020001 · PX20240103 · No.2024-2-2028 · Z241100007724004 · BRWEP2024W162020100 · BRWEP2024W162020112 · YC202401QX0824 · 82300646 · [ZHKY-2025-1869（B012）] · No.2024ZD0520600

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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