Clinical trial NCT04303286: The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
Official title: The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gut Microbiota
Hepatocellular Carcinoma
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort are the patients from the hepatic surgery of Tongji hospital.

Brief summary: The purpose of this study was to explore the correlation between postoperative recovery of liver function and gut microbiota in patients with hepatocellular carcinoma (HCC). Liver resection patients were divided into the recovery group and the recovery delay group according to the recovery level of liver function on the fifth day after the operation. Benign liver disease was used as a control. Statistical analysis was performed to compare the differences in gut microbiota between the three groups. Then, fecal microbiota transplantation was performed in a mouse hepatectomy model. Through this study, the investigators hope to understand the relationship between gut microbiota and postoperative recovery of liver function in patients with hepatocellular carcinoma, so as to provide a new therapeutic direction for patients in the aspect of perioperative liver function recovery.

Detailed description: Primary hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world. At present, surgery is the first choice and the most effective way to treat it. Based on the case review, the investigators found that the recovery rate of perioperative liver function was correlated with survival. Therefore, it is of great clinical significance to improve the recovery rate of postoperative liver function. Gut microbiota participate in many physiological activities of human body, such as metabolic regulation, immune homeostasis and hormone regulation. However, gut microbiota imbalance, excessive growth of pathogenic microorganisms and changes in intestinal mucosal permeability lead to intestinal bacterial ectopia and bacterial metabolites entering the liver through enterohepatic circulation. The continuous inflammatory stimulation aggravate the progress of liver disease. Therefore, it is helpful to explore the influence of gut microbiota on postoperative liver function recovery and find out the different microbiota, in order to improve the postoperative liver function recovery rate, shorten the perioperative hospital stay and prolong the survival of patients.

According to the recovery level of liver function on the fifth day after the operation, liver resection patients on HCC were divided into the recovery group and the recovery delay group which comparing on the time point of before the surgery and five days after the surgery. The patients on benign liver disease were used as a control. The investigators attempt to identify the differential microbiota and validate this finding in a mouse hepatectomy model.

Eligibility criteria: Inclusion Criteria:

* The patient is diagnosed with liver cancer by b-mode ultrasonography before the surgery.
* There is no antibiotic treatment, no severe diarrhea and regular diet within two weeks before the surgery.
* It perform laparoscopic or open hepatectomy.
* The postoperative pathological diagnosis is hepatocellular carcinoma.

Exclusion Criteria:

* No hepatectomy is performed during the operation.
* The patient is't hepatocellular carcinoma due to the postoperative pathological diagnosis.
* No stool samples are collected during the perioperative period.

Primary outcomes:
measure: Diversity analysis
timeFrame: Before the surgery
measure: Diversity analysis
timeFrame: Five days after the surgery
measure: Species composition analysis
timeFrame: Before the surgery
measure: Species composition analysis
timeFrame: Five days after the surgery
measure: Species differential analysis
timeFrame: Before the surgery
measure: Species differential analysis
timeFrame: Five days after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: The hepatic surgery of Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Bixiang Zhang
role: STUDY_CHAIR
affiliation: Tongji Hospital
name: Jingjing Yu
role: PRINCIPAL_INVESTIGATOR
References: