Gastric Cancer
Conditions
Keywords
gastric cancer, neoadjuvant chemotherapy, enhanced recovery after surgery, gastrectomy
Brief summary
Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.
Detailed description
In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.
Interventions
PROCEDURENAC group
NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.
PROCEDURESurgery alone group
Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.
Sponsors
JIANG Zhi-Wei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a single-center, parallel, open-label randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with locally advanced gastric cancer. 2. Age older than 18 and younger than 75 years. 3. American Society of Anesthesiologists (ASA) class: I-III. 4. Participants can describe the symptom objectively and cooperate actively. 5. Written informed consent
Exclusion criteria
1. Patients allergic to oxaliplatin, tegafur gimerac etc. 2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \> II (NYHA) 3. Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. 4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr \< 25 ml/min). 5. Patients who require simultaneous surgery for other diseases. 6. Patients who received upper abdominal surgery previously. 7. Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative length of stay | 1 month | Postoperative length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to first flatus | 1 week | Bowel recovery |
| Time to semi-liquid diet | 2 weeks | Bowel recovery |
| Postoperative complications | 2 months | Postoperative complications |
| Albumin | 1 week | Nutritional status |
| Prealbumin | 1 week | Nutritional status |
| Total protein | 1 week | Nutritional status |
Countries
China
Outcome results
None listed