The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303286
• Other study ID #: TJ-IRB20191223
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Gut Microbiota
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	The hepatic surgery of Tongji hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diversity analysis	We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.	Before the surgery
Primary	Diversity analysis	We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.	Five days after the surgery
Primary	Species composition analysis	We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample.	Before the surgery
Primary	Species composition analysis	We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample.	Five days after the surgery
Primary	Species differential analysis	We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA?PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.	Before the surgery
Primary	Species differential analysis	We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA?PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.	Five days after the surgery