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

NCT ID: NCT04303286

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Gut Microbiota Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recovery Group

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

No interventions assigned to this group

Recovery Delay Group

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

No interventions assigned to this group

Control Group

The patients on benign disease of the liver

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Bi Xiang, MD

Chairman of Department of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bixiang Zhang

Role: STUDY_CHAIR

Tongji Hospital

Jingjing Yu

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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The hepatic surgery of Tongji hospital

Wuhan, Hubei, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38091982 (View on PubMed)

Other Identifiers

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TJ-IRB20191223

Identifier Type: -

Identifier Source: org_study_id

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