Gastric Cancer Stage I
Conditions
Keywords
Gastric Cancer
Brief summary
Nowadays, while pursuing the eradication of tumor, how to maximize the preservation of normal anatomy and physiological functions of the stomach, reduce the surgical trauma caused by excessive debridement, and improve the quality of life of patients after surgery has become a more important concern in the treatment of early gastric cancer. This prospective multicenter randomized controlled clinical trial was designed to elucidate the oncologic safety of laparoscopic gastric preservation surgery compared to standard laparoscopic gastrectomy. The oncologic safety of laparoscopic gastric preservation surgery with anterior basal dissection (SBD) compared to standard laparoscopic gastrectomy. This trial is an investigator-initiated, multicenter, prospective, randomized, open, parallel-controlled with a non-inferiority design. Patients diagnosed as distal gastric cancer with clinical stage T1N0M0, with a lesion diameter of 3 cm or less were eligible to participate in this study. Patients will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival.
Interventions
PROCEDURELaparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area
A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method., and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing.If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed.
Sponsors
Tongzhou District Hospital
Haimen People's Hospital
Dongtai People's Hospital
Qidong City People's Hospital
Rudong County Hospital of Traditional Chinese Medicine
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
1. The group of laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area. 2. Patients in the control group will undergo standard laparoscopic gastrectomy (laparoscopic distal gastrectomy with simultaneous D1+ lymph node dissection).
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
： 1. single lesion detected by gastroscopy and clearly diagnosed histologically as gastric adenocarcinoma. 2. patients with gastric cancer with clinical stage T1N0M0 (based on the TNM stage of the 8th edition of AJCC) (T-stage assessed by ultrasound gastroscopy and N-stage and M-stage assessed by enhanced CT). 3. tumor length diameter less than 3 cm. 4. the lesion is located in the gastric sinus. 5. patient age greater than 20 years and less than 80 years. 6. ECOG score of 0 or 1. 7. The patient voluntarily participated in this clinical study.
Exclusion criteria
1. Patients with gastric cancer suitable for endoscopic treatment (differentiated gastric cancer with tumor length diameter less than 2 cm and located within the mucosa). 2. cardiopulmonary dysfunction that cannot tolerate laparotomy. 3. pyloric duct gastric cancer. 4. Previously undergone upper abdominal surgery. 5. other malignant tumors diagnosed within the previous five years. 6. Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) at three years | three years | The criteria for DFS events in this study were as follows: recurrence of the primary tumor at the incisional margin or anastomosis, heterochronic metastasis in the remnant stomach, histologically or imaging confirmed intraperitoneal recurrence, lymph node metastasis, distant metastasis, new malignancy in other organs, and other causes of death. |
Countries
China
Contacts
Primary ContactQinSheng Mao
Outcome results
None listed