Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer（IDEAL Stage 2b）
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery, Laparoscopic D2 radical gastrectomy.
- Who it may be relevant to
- Registry conditions: Early Gastric Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fluorescence Guided Laparoscopic-Endoscopic Cooperative Sentinel Lymph Node Navigation Surgery Strategy for Early Gastric Cancer: A Multicenter Randomized Controlled Trial Study
Overview
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.
Detailed description
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.
Interventions
- Procedure 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 - Procedure 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
Primary outcome measures
- 3 and 5-year disease free survival [Time frame: From treatment to 3 and 5-years after surgery]
Secondary outcome measures (12)
- 5-year overall survival [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: From treatment to 30-days after surgery]
- Operation time [Time frame: From treatment to 1 week after surgery]
- R0 resection rate [Time frame: From treatment to 1 week after surgery]
- additional surgical operation rate [Time frame: From treatment to 5-years after surgery]
- blood loss [Time frame: From treatment to 30-days after surgery]
- postoperative length of stay [Time frame: From treatment to 30-days after surgery]
- overall hospitalization cost [Time frame: From treatment to 5-years after surgery]
- Gastric emptying scintigraphy result [Time frame: From treatment to 5-years after surgery]
- date of gas evacuation [Time frame: From treatment to 30-days after surgery]
Eligibility criteria
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.
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.
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Friendship Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06788548 · BRWEP2024W162020112 · 7232334 · D171100006517003 · PX2020001 · PX20240103 · No.2024-2-2028 · Z241100007724004 · BRWEP2024W162020100 · BRWEP2024W162020112 · YC202401QX0824 · 82300646 · [ZHKY-2025-1869（B012）] · No.2024ZD0520600