Early Gastric Cancer
Conditions
Keywords
Early Gastric Cancer, Sentinel Lymph Node, Basin Dissection, Laparoscopic surgery, Safety AND Efficacy, Fluorescence Guided, Laparoscopic-Endoscopic Cooperative Surgery, multicenter
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. 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
PROCEDUREFluorescence 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 laparoscopic sentinel node basin dissection (LSBD), indocyanine green (ICG) (2 mL, 2.5 mg/mL) was endoscopically injected into the submucosal layer at four quadrants around the marking points (0.5 mL per quadrant). Fifteen minutes after ICG injection, sentinel lymph node basins (SLBs) were defined as the area within a 2 cm margin of the detected fluorescence stained nodes, which were marked with laparoscopic clips.
PROCEDURELaparoscopic 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: The lesser omentum is divided near the liver, reaching the cardia and diaphragm. The gastrocolic ligament is divided along the transverse colon. Lymph node dissection begins along the splenic artery, then proceeds to the left gastric artery and celiac nodes. The left gastric vessels are controlled with endoclips.After lymph node dissection, distal subtotal gastrectomy is performed. Digestive tract reconstruction is typically done through a mini-laparotomy.
Sponsors
Beijing Friendship Hospital
China-Japan Friendship Hospital
Cancer Hospital Chinese Academy of Medical Scienc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease-free survival (DFS) rate | From date of surgery to up to 3 years post-surgery | DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative gastroscopy composite adverse findings | From date of surgery to up to 5 years post-surgery | Proportion of participants with any of the following adverse findings on surveillance endoscopy: poor anastomotic healing, residual lesions, metachronous lesions, or local recurrence. Participants are counted once if they meet any of these criteria. |
| Postoperative CT composite findings | From date of surgery to up to 5 years post-surgery | Proportion of participants with any of the following adverse findings on contrast-enhanced CT of the chest, abdomen, and pelvis: local recurrence, distant metastasis, or abnormal lymph nodes. |
| Postoperative histopathological composite findings | From date of surgery to up to 5 years post-surgery | Proportion of participants with positive findings for malignancy on histopathological examination of biopsy specimens obtained during scheduled follow-up endoscopy or additional surgery. |
| EORTC QLQ-C30 | From 30 days prior to surgery to 5 years post-surgery | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. |
| EORTC QLQ-STO22 | From 30 days prior to surgery to 5 years post-surgery | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden. |
| PGSAS-45 | From 30 days prior to surgery to 5 years post-surgery | The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions. All subscale scores are linearly transformed to a 0-100 range. For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life. |
| Prealbumin | From 30 days prior to surgery to 5 years post-surgery | — |
| 5-year disease-free survival (DFS) rate | From date of surgery to up to 5 years post-surgery | DFS is defined as the time from the date of surgery to the date of first documented tumor recurrence, metastasis, or death from any cause. |
| 3-year overall survival (OS) rate | From date of surgery to up to 3 years post-surgery | OS is defined as the time from the date of surgery to death from any cause. |
| 5-year overall survival (OS) rate | From date of surgery to up to 5 years post-surgery | OS is defined as the time from the date of surgery to death from any cause. |
| 3-year recurrence-free survival (RFS) rate | From date of surgery to up to 3 years post-surgery | RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence. |
| 5-year recurrence-free survival (RFS) rate | From date of surgery to up to 5 years post-surgery | RFS is defined as the time from the date of surgery to the first occurrence of disease recurrence. |
| 3-year disease-specific survival (DSS) rate | From date of surgery to up to 3 years post-surgery | DSS is defined as the length of time that the patients survived from the time of randomization or treatment initiation until death from the specific disease in question. |
| 5-year disease-specific survival (DSS) rate | From date of surgery to up to 5 years post-surgery | DSS is defined as the length of time that the patients survived from the time of randomization or treatment initiation until death from the specific disease in question |
| 3-year progression-free survival (PFS) rate | From date of surgery to up to 3 years post-surgery | PFS is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease. |
| 5-year progression-free survival (PFS) rate | From date of surgery to up to 5 years post-surgery | PFS is defined as the time from the date of surgery to the first occurrence of either disease progression or death from any cause. Disease progression includes recurrence, metastasis, or progression of residual disease. |
| 30-day postoperative mortality | From the date of surgery to 30 days post-surgery | All-cause mortality occurring within 30 days after surgery. |
| 30-day postoperative morbidity | From the date of surgery to 30 days post-surgery | Postoperative complications occurring within 30 days will be recorded, including bleeding, perforation, lymphatic leakage, respiratory complications, cardiovascular complications, anastomotic fistula, according to the Clavien-Dindo scale |
| Unscheduled Second Surgery Rate | From the date of surgery to 30 days post-surgery | Rate of unscheduled reoperation within 30 days after the initial surgery |
| Unplanned Return to Hospital Rate | From the date of surgery to 30 days post-surgery | Rate of unplanned hospital readmission within 30 days after discharge following the initial surgery |
| Rate of inconsistent result between intraoperative rapid pathology and postoperative pathology examine | From the date of surgery to 7 days post-surgery | — |
| Operation time | At the time of surgery | — |
| Operation method | At the time of surgery | — |
| R0 resection rate | From date of surgery to 7 days post-surgery | Proportion of patients with no residual tumor microscopically confirmed on both the primary tumor resection margins and resected lymph nodes, assessed by postoperative pathological examination. |
| Remedial and additional surgery rate | From the date of surgery to 30 days post-surgery | Proportion of patients requiring additional surgical procedures due to intraoperative or postoperative pathological findings |
| Intraoperative Blood Loss | At the time of surgery | Estimated total volume of blood loss during the surgical procedure |
| Postoperative Length of Stay | From date of surgery until date of hospital discharge, assessed up to 2 weeks | Total number of days from the date of surgery to hospital discharge |
| Average Length of Stay | From date of surgery until date of hospital discharge, assessed up to 2 weeks | Average number of days from the date of surgery to hospital discharge |
| Overall Hospitalization Cost | From the time of admission to the time of discharge, assessed up to 3 weeks | — |
| Gastric Emptying Scintigraphy | From 30 days prior to surgery to 5 years post-surgery | It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy. |
| Time to First Flatus | From date of surgery until date of hospital discharge, assessed up to 2 weeks | Time from the date of surgery to the first passage of flatus, indicating recovery of gastrointestinal motility. |
| Serum Total Protein | From 30 days prior to surgery to 5 years post-surgery | — |
| Albumin | From 30 days prior to surgery to 5 years post-surgery | — |
| Prognostic Nutritional Index (PNI) | From 30 days prior to surgery to 5 years post-surgery | It is a combined score based on serum albumin level and total lymphocyte count. It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL). Higher scores indicate better nutritional and immunological status. |
| Hemoglobin | From 30 days prior to surgery to 5 years post-surgery | — |
Countries
China
Contacts
CONTACTZheng Zhi, Doctor
Outcome results
None listed