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

NCT04303286 | Completed

• 1 other identifier: TJ-IRB20191223
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Recovery Group

The liver function of HCC patients on the fifth day after the operation is recovered.

Recovery Delay Group

The liver function of HCC patients on the fifth day after the operation is delayed recovered.

Control Group

The patients on benign disease of the liver

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort are the patients from the hepatic surgery of Tongji hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

The hepatic surgery of Tongji hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Yu J, Zhu P, Shi L, Gao N, Li Y, Shu C, Xu Y, Yu Y, He J, Guo D, Zhang X, Wang X, Shao S, Dong W, Wang Y, Zhang W, Zhang W, Chen WH, Chen X, Liu Z, Yang X, Zhang B. Bifidobacterium longum promotes postoperative liver function recovery in patients with hepatocellular carcinoma. Cell Host Microbe. 2024 Jan 10;32(1):131-144.e6. doi: 10.1016/j.chom.2023.11.011. Epub 2023 Dec 12.

  PMID: 38091982 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

feces, whole blood

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bixiang Zhang

  Tongji Hospital

  STUDY CHAIR

• Jingjing Yu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of General Surgery

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 11, 2020
• Study Start: October 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

CN (1)