Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b
For patients and families
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: Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und.
- Who it may be relevant to
- Registry conditions: Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy. Basic parameters: 18 years — 70 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
- Center list to be confirmed — check the primary protocol.
- 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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Overview
For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.
Interventions
- Procedure Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und
Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection. Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b. Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed
Primary outcome measures
- Rate of recurrence [Time frame: Within 2 years]
Secondary outcome measures (1)
- The operation time, complications and hospital stay were recorded [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Age 18-70 years old;
- Endoscopic pathological diagnosis: adenocarcinoma;
- Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0.
- Has not received other treatment;
- No other serious comorbidities;
- Agree to participate in the study and sign the informed consent form.
Exclusion criteria
- Pregnant or breastfeeding women
- History of previous abdominal surgery
- History of other previous malignancies
- Can patients with severe heart, lung, brain diseases tolerate surgical treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06934824 · FUTURE11