Gastric Cancer, Neoadjuvant Chemotherapy
Conditions
Brief summary
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.
Interventions
DRUGlive combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
Probiotics capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. Each capsule contained\>10,000,000 colony-forming units (CFUs). This drug can treat endoxemia caused by imbalance of intestinal flora.
Sponsors
Qilu Hospital of Shandong University
Qianfoshan Hospital
Shandong Provincial Hospital
Yantai Yuhuangding Hospital
Jining First People's Hospital
Weifang Medical University
Weifang People's Hospital
Dongying People's Hospital
Weihai Municipal Hospital
Weihai Central Hospital
Rizhao People's Hospital
Liaocheng People's Hospital
Qingdao Municipal Hospital
The Second Hospital of Shandong University
The People's Hospital of Jimo.Qingdao
Binzhou People's Hospital
Binzhou Medical University
Jinan Central Hospital
Shandong Cancer Hospital and Institute
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative infectious complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative death and readmission | up tp 30 days after surgery | postoperative death and readmission within 30 days after surgery |
| duration of therapeutic antibiotic use | up tp 30 days after surgery | duration of therapeutic antibiotic use measured as day |
| time to postoperative adjuvant chemotherapy | up tp 30 days after surgery | durition from surgery to postoperative adjuvant chemotherapy. |
| European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 (EORTC QLQ-C30) (V3.0) | on postoperative day 30 | The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30, Higher scores for functional areas and general health indicate better functional status and quality of life, and higher scores for symptom areas indicate more symptoms or medical problems. The minimum value is 0 and maximum value is 100. |
| Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 | on postoperative day 3, 5, and 30 | Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100 |
| visual analogue scale | on postoperative day 1, 3 and 5 | from minimum 0 to maximun 10, higher score means more pain. |
| postoperative recovery parameter | up tp 30 days after surgery | time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay; |
| percent of neutrophile granulocyte | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is %, recorded respectively according to measure time |
| procalcitonin | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is pg/ml, recorded respectively according to measure time |
| C-reactive protein | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is mg/L, recorded respectively according to measure time |
| albumin | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is \*g/L, recorded respectively according to measure time |
| prealbumin | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is mg/L, recorded respectively according to measure time |
| total bilirubin | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is μmol/L, recorded respectively according to measure time |
| Leukocyte Count | Postoperative, on postoperative day 1, 3 and 5 | unit of measurement is \*10\^9/L, recorded respectively according to measure time |
Countries
China
Contacts
Primary ContactYanbing Zhou, MD
Backup ContactGan Liu, MD
Outcome results
None listed