Clinical trial NCT05160753: Laparoscopic Gastric Function Preserving Surgery Combined With Resection of the Anterior Lymphatic Drainage Area
Official title: Laparoscopic Gastric Function Preserving Surgery Combined With Resection of the Anterior Lymphatic Drainage Area. Comparison of Laparoscopic Standard Radical Gastric Cancer Surgery for Early Distal Gastric Cancer Multicenter, Prospective, Randomized, Open, Parallel-controlled, Non-inferiority Efficacy Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer Stage I
Keywords: Gastric Cancer
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Tongzhou District Hospital
name: Haimen People's Hospital
name: Dongtai People's Hospital
name: Qidong City People's Hospital
name: Rudong County Hospital of Traditional Chinese Medicine
First posted: 2021-12-16
Enrollment: 580
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival (DFS) at three years
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
Study officials:
References:
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