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Effect of Gastrectomy on Gut Microbiome and Cognitive Function

Effects of Total Gastrectomy or Double Track Reconstruction on Gut Microbiome and Cognitive Function in Patients With Proximal Gastric Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06186089
Enrollment
45
Registered
2023-12-29
Start date
2024-01-20
Completion date
2026-06-30
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Perioperative Neurocognitive Disorders

Keywords

Perioperative neurocognitive disorders, proximal gastric cancer, gut microbiota, double-tract reconstruction

Brief summary

Perioperative neurocognitive disorders is a common postoperative complication in elderly surgical patients. The role of gut microbiota in cognitive function has been concerned in recent years. Studies suggests that gastrointestinal surgery may affect the gut microbiota, and the effect varies between surgical procedures. In this study, the investigators will compare the differences of gut microbiota between total gastrectomy and double-tract reconstruction, to investigate the effect of gastric acid on the gut microbiota colonizing, and the effect of different surgical procedures on the postoperative cognitive function of proximal gastric cancer patients.

Detailed description

Perioperative neurocognitive disorders is a common postoperative complication in elderly surgical patients, especially in gastrointestinal tumors and cardiac on-pump surgery, and the mechanism is not clear yet. The role of gut microbiota in cognitive function has been concerned in recent years, and the applicant's previous study also found significant differences in the composition of gut microbiota and metabolites in elderly orthopedic surgical patients with postoperative cognitive dysfunction compared with the control group, and that the differential metabolites were mainly enriched in the metabolic pathway of protein digestion and absorption. Studies suggests that gastrointestinal surgery may affect the gut microbiota, and the effect varies between surgical procedures. The incidence of proximal gastric cancer is increasing. In order to prevent severe gastroesophageal reflux, total gastrectomy is mostly performed. However, after total gastrectomy, food directly enters into the intestine, followed by insufficient mixing of gastric acid and food. Patients are prone to nutrient absorption disorders, which may cause changes in gut microbiota. The double-tract reconstruction allows food to enter the distal gastrointestinal tract via two pathways, successfully solving the problems of gastroesophageal reflux, gastroparesis, and long-term nutritional disorders in patients after proximal gastrectomy. In this study, the investigators aim to investigate the effect of gastric acid on the gut microbiota colonizing, and the effect of different surgical procedures on the postoperative cognitive function of proximal gastric cancer patients. The investigators will compare the differences of gut microbiota between total gastrectomy and double-tract reconstruction by 16S ribosomal ribonucleic acid (rRNA) gene sequencing and metabonomics technology, and evaluate the postoperative cognitive function by Mini-mental State Examination scales and Montreal Cognitive Assessment scales.

Interventions

DIETARY_SUPPLEMENTprobiotics

patients undergoing total gastrectomy take probiotics qd for 3 months

Sponsors

Jiangjiang Bi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Clinical diagnosis of proximal gastric cancer and will be performed gastrectomy 2. American Society of Anesthesiologists (ASA) classification I-III 3. Aged 40-80 years 4. Perioperative consciousness

Exclusion criteria

1. Central nervous system and psychological disorders 2. Chronic use of sedatives, antidepressants within the last year 3. Parkinson's disease 4. Severe immunosuppression 5. Severe hearing or vision impairment 6. Drug dependence; alcoholism 7. Inability to communicate with a physician

Design outcomes

Primary

MeasureTime frameDescription
Composition and diversity of gut microbiota1 day before surgery and 7 days after surgeryIt will be tested by 16s rRNA gene sequencing.
Cognitive function1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgeryThe participants will be evaluated by Mini-mental State Examination scales, and diagnosed as cognitive dysfunction if score \< 24.

Secondary

MeasureTime frameDescription
Inflammatory factorpreoperation, 30 minutes and 24 hours after surgeryInterleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α), C reactive protein (CRP) will be tested by ELISA kit.

Countries

China

Contacts

Primary ContactJiangjiang Bi, MD
bessie8210@163.com862783665431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026