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Clinical study on the effect of mild type of hepatic encephalopathy on postoperative recovery of patients with primary liver cancer treated with minimal hepatic encephalopathy

Clinical study on the effect of mild type of hepatic encephalopathy on postoperative recovery of patients with primary liver cancer treated with minimal hepatic encephalopathy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078610
Enrollment
Unknown
Registered
2023-12-13
Start date
2023-03-22
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MHE

Interventions

intervention group:On the basis of routine clinical treatment, lactulose oral liquid was given 10ml, and the dosage for patients with constipation could be increased to 30ml, which could be adjusted a
Control group (No MHE):Clinical routine treatment, PHES after admission
Control group (MHE):Clinical routine treatment, PHES, quality of life and other evaluations were carried out on the morning of the day of surgery, and minimally invasive treatment surgery was performe
Healthy group:Take the PHES test

Sponsors

The Fifth Medical Centre PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1Inclusion criteria for healthy people (1) Inclusion criteria ? 18 years = age = 80 years; (2) Healthy individuals or those with common diseases that do not affect this study. 2Inclusion criteria for patients (1) Inclusion criteria ?18 years old = age = 80 years old; ?Patients with a diagnosis of cirrhosis in accordance with our 2020 Guidelines for the Treatment of Cirrhosis or Evidence-based clinical practice guidelines for liver cirrhosis by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver" diagnostic criteria; ? The patient's liver cancer diagnosis meets the diagnostic criteria of the Primary Liver Cancer Treatment Guidelines (2022) Edition or the AASLD Guidelines for the Treatment of Hepatocellular Carcinoma by the AASLD; ? the patient's liver function evaluation and tumor stage are consistent with the indications for radical or palliative minimally invasive ablation therapy (argon helium knife, microwave ablation therapy), and receives minimally invasive ablation therapy; ? Patients can accept and complete PHES testing.

Exclusion criteria

Exclusion criteria: 1. Healthy people exclusion criteria ?Patients with acute and chronic liver disease, kidney disease or heart disease; ?Patients with comorbid neurological diseases as well as psychological disorders, or those who use psychotropic drugs; ?Patients with diseases related to eye, ear and hand movement disorders, or those who are unable to perform PHES tests due to hearing, vision or intelligence; ? a history of long-term heavy alcohol consumption (average daily alcohol equivalent > 40 g/d for > 5 years) ? those who do not have the ability to read and write ?Those who refused to undergo PHES testing. (?) Those who were deemed unsuitable for enrollment for other reasons by the investigator. 2. Patient exclusion criteria ?Patients who cannot accept or do not meet the indications for minimally invasive ablation treatment; ?Participation in other clinical trials within the previous 30 days; ?Patients with combined neurological or psychological disorders, or those who use psychotropic drugs; (iv) Patients who have undergone ablation therapy in combination with other treatments: interventional, targeted therapy, immunotherapy, radiotherapy, etc. during this treatment period; ? Those who are unable to perform PHES test due to hearing, vision, intelligence, etc; (6) Patients with other combined diseases that significantly affect the quality of life evaluation; (vii) Patients who cannot undergo PHES test; ? Those who do not have the ability to read and write; ? Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of Adverse Events;

Secondary

MeasureTime frame
the patient reported outcomes;PHES test scores;Lactulose treatment is effective;

Countries

China

Contacts

Public ContactGao Xudong

The Fifth Medical Centre PLA General Hospital

gao19751@163.com+86 150 1010 9589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026