early gastric cancer
Conditions
Interventions
non-total resection + follow-up group:non-total resection
Total resection + postoperative chemotherapy group:Total resection
Non-total resection + lymph node dissection group:Non-total resection + lymph node dissection
Supplementary surgical operation group after nontotal resection:Supplementary surgical operation after nontotal resection
Non-total resection + postoperative chemotherapy group:Non-total resection + postoperative chemotherapy
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for full-layer resection of lesions: (1) Preoperative biopsy pathology indicated that HIN was cancerous or cancerous; Lesion size<=3cm. (2) Complete clinical stage diagnosis was performed before surgery, including chest CT plain scan, abdominal pelvic CT plain scan + enhancement, superficial lymph node ultrasound, PET-CT, endoscopy and magnification endoscopy; (3) The clinical stage of gastric cancer was cTisN0M0, cT1aN0M0 or cT1bN0M0; (4) Age :18-80 years old; (5) Endoscopic therapy and laparoscopic lymph node resection are generally tolerated; (6) Patients and family members can understand the research protocol and voluntarily participate in the study, and sign informed consent. After that, according to postoperative pathology, the selection of patients in the real world was subdivided into eCureA, grade B, follow-up; The patients were enrolled in the group of total resection and follow-up. eCureC level, using a risk score system to assess the risk of lymph node metastasis: Low-risk group (2.5% risk of lymph node metastasis) and medium-risk group (6.7% risk of lymph node metastasis) were divided into simple total resection + follow-up group, total resection + postoperative chemotherapy group, total resection + lymph node dissection group, and supplemented surgical operation group after total resection according to the actual conditions and wishes of patients. High-risk group (22.7% risk of lymph node metastasis) was divided into total resection + postoperative chemotherapy group, total resection + lymph node dissection group, and supplementary surgical operation group after total resection according to the actual condition and willingness of patients The inclusion criteria of the non-full-layer resection group were as follows: (1) Preoperative biopsy pathology indicated HIN with or without cancer; The size of the lesion is not limited. (2) Complete clinical stage diagnosis was performed before surgery, including chest CT plain scan, abdominal pelvic CT plain scan + enhancement, superficial lymph node ultrasound, PET-CT, endoscopy and magnification endoscopy; (3) The clinical stage was cTisN0M0 gastric early cancer or gastric HIN; (4) Age :18-80 years old; (5) Endoscopic therapy and laparoscopic lymph node resection are generally tolerated; (6) Patients and family members can understand the research protocol and voluntarily participate in the study, and sign informed consent. After that, according to postoperative pathology, the selection of patients in the real world was subdivided into eCureA, grade B, follow-up; The patients were enrolled in the non-total resection + follow-up group. eCureC level, using a risk score system to assess the risk of lymph node metastasis: Low-risk group (2.5% risk of lymph node metastasis) and medium-risk group (6.7% risk of lymph node metastasis) were divided into simple non-total resection + follow-up group, total resection + postoperative chemotherapy group, non-total resection + lymph node dissection group, and supplemented surgical operation group after non-total resection according to the actual conditions and wishes of patients. High-risk group (22.7% risk of lymph node metastasis) was divided into non-total resection + postoperative chemotherapy group, non-total resection + lymph node dissection group, and supplementary surgical operation group after non-total resection according to the actual condition and willingness of patients. The inclusion criteria of the surgical group
Exclusion criteria
Exclusion criteria: (1) Previous history of gastrointestinal surgery; (2) There is a history of malignant tumors or other malignant tumors; (3) Combined with gastrointestinal bleeding and other emergencies; (4) Special groups: children, pregnant or lactating women, patients with mental illness; (5) Situations in which the researcher considers it inappropriate to be included; (6) Lymph node sampling or report did not meet the criteria of this study; (7) Nano carbon or indocyanine green allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival in 2 years;Disease Free Survival; | — |
Countries
China
Contacts
Public ContactEnqiang Linghu
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed