Clinical trial NCT05178524: Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
Official title: Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Hepatocellular Carcinoma
Bifidobacterium
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: On the basis of previous studies, this study intends to explore the effect of BIFICO on liver function recovery of patients with hepatocellular carcinoma (HCC) after surgery, so as to provide a new method for accelerating liver function recovery of HCC patients during perioperative period.

This project is an open, randomized, blank-controlled clinical study. Liver resection patients were randomly divided into two groups, one group received continuous administration of BIFICO during perioperative period, and the dosage was controlled according to the instructions. The other group was a blank control. Stool samples were collected at three time points (before medication, before and after surgery) in two groups. Statistical analysis was performed to compare the differences of postoperative liver function and preoperative and postoperative gut microbiota between the two groups.

Through this study, the investigators aimed to verify the beneficial changes of intestinal microflora in HCC patients with BIFICO during perioperative period .

Detailed description: Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the digestive system, with a high incidence in the world and the third highest mortality rate among all malignant tumors in China. In recent years, studies have found that intestinal microflora disorder can also promote the occurrence and development of HCC through various ways, such as endotoxemia, metabolic disorders, and increased risk of exposure to HBV and aflatoxin. In the treatment of HCC, in addition to the traditional comprehensive treatment based on surgical resection, the treatment for intestinal microflora disorder also plays a unique role in improving prognosis and alleviating complications.

At present, increasing the number of beneficial bacteria through probiotics is an important method to restore the ecological balance of intestinal microorganisms. Probiotics can maintain the balance of intestinal microecology and the integrity of intestinal mucosal barrier by inhibiting the growth of harmful bacteria, stimulating fermentation, stimulating the proliferation of intestinal mucosal cells and activating the immune system.

The preliminary study of this project has shown that the difference of intestinal flora in patients with HCC has a certain impact on the recovery speed of liver function after hepatectomy, and the core flora affecting postoperative liver function is bifidobacteria. Meanwhile, animal experiments have also verified that bifidobacteria can improve the postoperative liver function of mice. Therefore, improving the structure and environment of intestinal microorganisms, increasing the colonization of beneficial bacteria and enhancing the diversity of bacteria are very important to accelerate the recovery of liver function after hepatectomy for patients with HCC.

In this project, it is planned to use bifidobacteria-rich BIFICO as an intervention drug to sustained medication in the perioperative period of hepatectomy patients with HCC, and observe the recovery of postoperative liver function.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 80 years old
* Imaging diagnosis of primary HCC, without other malignancies
* No antibiotic treatment within two weeks before surgery
* Regular diet and no severe diarrhea
* Laparoscopic or open hepatectomy is performed

Exclusion Criteria:

* No liver resection is performed
* No preoperative or postoperative stool samples during the perioperative period
* Pathological diagnosis is not HCC

Primary outcomes:
measure: Comparison of liver function recovery with total bilirubin and prothrombin activity
timeFrame: Five days after the surgery
measure: The alpha and beta diversity analysis of gut microbiota
timeFrame: Baseline (Before the surgery)
measure: The alpha and beta diversity analysis of gut microbiota
timeFrame: Five days after the surgery
measure: Species composition and differential analysis of gut microbiota
timeFrame: Baseline (Before the surgery)
measure: Species composition and differential analysis of gut microbiota
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: