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| Name | Class |
|---|---|
| Qilu Hospital of Shandong University | OTHER |
| Qianfoshan Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Yantai Yuhuangding Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | Experimental | 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. |
|
| Control Group | No Intervention | CG (Control Group) patients receive blank control management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative infectious complications | 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. | up tp 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative recovery parameter | time to first postoperative flatus and bowel movement; time to solid food tolerance; postoperative hospital stay; | up tp 30 days after surgery |
| postoperative death and readmission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbing Zhou, MD | Contact | 86532-82911324 | zhouyanbing@qduhospital.cn | |
| Gan Liu, MD | Contact | 86532-82911324 | docliu163@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanbing Zhou, MD | The Affiliated Hospital of Qingdao University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital | Recruiting | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40281451 | Derived | Liu G, Cao S, Liu X, Tian Y, Yu W, Chai J, Li L, Wang X, Chu X, Duan Q, Qu J, Wang H, Zhang H, Wang X, Hui X, Yang D, Zhou S, Ding Y, Wang H, Zhou F, Hu B, Guo P, Jiang L, Zhang G, Pan Q, Zhou X, Zhou Y. Effect of perioperative probiotic supplements on the short-term clinical outcomes of patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy: Study protocol for a multicenter randomized controlled trial (GISSG2023 - 01 Study). BMC Cancer. 2025 Apr 25;25(1):776. doi: 10.1186/s12885-025-14115-x. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| OTHER |
| Jining First People's Hospital | OTHER |
| Weifang Medical University | OTHER |
| Weifang People's Hospital | OTHER |
| Dongying People's Hospital | OTHER |
| Weihai Municipal Hospital | OTHER |
| Weihai Central Hospital | OTHER |
| Rizhao People's Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| Qingdao Municipal Hospital | OTHER |
| The Second Hospital of Shandong University | OTHER |
| The People's Hospital of Jimo.Qingdao | UNKNOWN |
| Binzhou People's Hospital | OTHER |
| Binzhou Medical University | OTHER |
| Jinan Central Hospital | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
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postoperative death and readmission within 30 days after surgery
| up tp 30 days after surgery |
| duration of therapeutic antibiotic use | duration of therapeutic antibiotic use measured as "day" | up tp 30 days after surgery |
| time to postoperative adjuvant chemotherapy | durition from surgery 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) | 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. | on postoperative day 30 |
| Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 | Higher score means more discomfort after gastrectomy. The minimum value is 0 and maximum value is 100 | on postoperative day 3, 5, and 30 |
| visual analogue scale | from minimum 0 to maximun 10, higher score means more pain. | on postoperative day 1, 3 and 5 |
| Leukocyte Count | unit of measurement is "*10^9/L", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| percent of neutrophile granulocyte | unit of measurement is "%", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| procalcitonin | unit of measurement is "pg/ml", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| C-reactive protein | unit of measurement is "mg/L", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| albumin | unit of measurement is "*g/L", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| prealbumin | unit of measurement is "mg/L", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| total bilirubin | unit of measurement is "μmol/L", recorded respectively according to measure time | Postoperative, on postoperative day 1, 3 and 5 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |