Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHebei Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Procedure/Surgery

    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 .

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of recurrence

Time frame
Within 2 years

Secondary outcomes

1

The operation time, complications and hospital stay were recorded

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: