Effect of Perioperative Probiotic Supplements on Postoperative Short-term Outcomes in Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy: A Prospective, Randomized, Controlled, Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- postoperative infectious complications
研究概览
简要总结
Background: Surgery can significantly improve the prognosis of patients with gastric cancer. However, some patients are at a later stage at diagnosis and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may lead to more postoperative complications. Probiotics have the potential to reduce postoperative complications and infections, but no large sample, multicentre, randomized clinical trials have been conducted in patients with gastric cancer receiving NACT. The aim of this multicentre randomized controlled trial was to investigate the effect of probiotics on postoperative infections and other short-term outcomes in patients with gastric cancer receiving NACT.
Methods/design: This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The experimental group will receive perioperative probiotic supplement and that of the control group will receive blank control management. An estimated 318 patients will be enrolled. The main endpoint for comparison is postoperative infections between the two groups.The experimental group patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •male and female
- •clinical stage was T3/4N+ evaluated by CT/MR/EUS at new diagnosis (before any anti-cancer treatment) , complete 2-4 cycles preoperative chemotherapy based on 5-FU (such as SOX, FLOX, ect.) at 3-6 weeks before surgery
- •ASA grade was Ⅰ~Ⅲ
- •radical minimal-invasive gastrectomy via laparoscope or DaVinci is judged as possible
- •histologically confirmed gastric adenocarcinoma
- •ECOG score is 0~1
- •patients who provide a written informed consent before entering study screening
排除标准
- •need emergency surgery due to performation and/or obstruction
- •receive antibiotics and/or glucocorticoids within 14 days before surgery
- •exist bacterial infection and/or autoimmune disease and/or IBD currently
- •intolerance or allergic to probiotics
- •upper abdominal surgery history
- •use probiotics within 7 days before intervention, such as yogurt, ect.
- •participate in other clinical trials currently
- •severe mental illness
- •can not participate in this trial due to severe illness of other organs evaluated by researchers, such as severe cardiac insufficiency (LVEF<30%, NYHA>Ⅱ, severe arrhythmia, congestive heart failure, myocardial infarction within 6 months), liver dysfunction (Child-Pugh C), renal dysfunction (need hemodialysis)
- •need simultaneous surgery
- •lactation or pregnancy
- •refuse to participate in this trial
研究组 & 干预措施
Probiotic Group
PG (probiotic group) patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. The intervention begins from the completion of preoperative chemotherapy to the seventh day after surgery.
干预措施: live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules (Drug)
结局指标
主要结局
postoperative infectious complications
时间窗: up tp 30 days after surgery
The primary outcome was the incidence of postoperative infectious complications, which were defined as bacterial infections within 30 d after surgery. The diagnosis of infectious complications was based on fever (≥38°C), elevation of C-reactive protein (CRP), specific clinical symptoms of infection, and positive bacterial culture.
次要结局
- postoperative recovery parameter(up tp 30 days after surgery)
- postoperative death and readmission(up tp 30 days after surgery)
- duration of therapeutic antibiotic use(up tp 30 days after surgery)
- time to postoperative adjuvant chemotherapy(up tp 30 days after surgery)
- European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0)(on postoperative day 30)
- Postgastrectomy Syndrome Assessment Scale (PGSAS)-45(on postoperative day 3, 5, and 30)
- visual analogue scale(on postoperative day 1, 3 and 5)
- Leukocyte Count(Postoperative, on postoperative day 1, 3 and 5)
- percent of neutrophile granulocyte(Postoperative, on postoperative day 1, 3 and 5)
- procalcitonin(Postoperative, on postoperative day 1, 3 and 5)
- C-reactive protein(Postoperative, on postoperative day 1, 3 and 5)
- albumin(Postoperative, on postoperative day 1, 3 and 5)
- prealbumin(Postoperative, on postoperative day 1, 3 and 5)
- total bilirubin(Postoperative, on postoperative day 1, 3 and 5)