Skip to content

An AI Model Based on Smartphone-derived Multimodality Images to Evaluate Portal Hypertension in Patients With Cirrhosis (CHESS2203)

An AI Model Based on Smartphone-derived Multimodality Images to Evaluate Portal Hypertension in Patients With Cirrhosis (CHESS2203)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05402410
Enrollment
1000
Registered
2022-06-02
Start date
2022-05-01
Completion date
2023-04-30
Last updated
2022-06-02

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

Conditions

Portal Hypertension

Keywords

cirrhosis, Traditional Chinese Medicine, artificial intelligence, portal hypertension, hepatic venous pressure gradient

Brief summary

Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Liver stiffness is currently the most widely used method for noninvasive assessment of portal hypertension. The renewing Baveno VII recommended that liver stiffness ≥ 25 kPa by transient elastography is sufficient to identify clinically significant portal hypertension (specificity and positive predictive value \> 90%). Although liver stiffness has a good predictive value for evaluation of clinically significant portal hypertension, it is difficult to apply in primary hospitals due to expensive equipment. Recently, a multicenter study has shown that artificial intelligence analysis based on ocular images can aid to screening and diagnosis hepatobiliary diseases. The patented technology of collecting and analyzing diagnostic images of Traditional Chinese Medicine (TCM) based on mobile phone terminals has been realized. This technology mainly includes image acquisition, quality control and analysis, and clinical information collection. Liver cirrhosis belongs to the diseases of bulging and accumulation in TCM, and the most common symptoms are the liver and gallbladder damp-heat and liver stagnation and spleen deficiency. The main contents of inspection diagnosis in TCM for liver disease include the images of the tongue, eye and palms. In our study, the patented technology of TCM based on artificial intelligence is applied to establish a precise evaluation model of traditional Chinese and western medicine for portal hypertension with cirrhosis by combining the macroscopic characteristics of images and microscopic pathological indicators.

Detailed description

Portal hypertension contributed to the main complications of liver cirrhosis. Currently, hepatic venous pressure gradient (HVPG) was the reference standard for evaluating portal pressure in patients with cirrhosis. However, the practice of HVPG is limited to require the extensive experience and highly specialized centers. In recent years, non-invasive methods were proposed to predict the degree of cirrhotic portal hypertension. Liver stiffness is currently the most widely used method for noninvasive assessment of portal hypertension. The renewing Baveno VII recommended that liver stiffness ≥ 25 kPa by transient elastography is sufficient to identify clinically significant portal hypertension (specificity and positive predictive value \> 90%). Although liver stiffness has a good predictive value for evaluation of clinically significant portal hypertension, it is difficult to apply in primary hospitals due to expensive equipment. Recently, a multicenter study has shown that artificial intelligence analysis based on ocular images can aid to screening and diagnosis hepatobiliary diseases. The patented technology of collecting and analyzing diagnostic images of Traditional Chinese Medicine based on mobile phone terminals has been realized. This technology mainly includes image acquisition, quality control and analysis, and clinical information collection. Liver cirrhosis belongs to the diseases of bulging and accumulation in Traditional Chinese Medicine, and the most common symptoms are the liver and gallbladder damp-heat and liver stagnation and spleen deficiency. The main contents of inspection diagnosis in Traditional Chinese Medicine for liver disease include the images of the tongue, eye and palms. In our study, the patented technology of Traditional Chinese Medicine based on artificial intelligence is applied to establish a precise evaluation model of traditional Chinese and western medicine for portal hypertension with cirrhosis by combining the macroscopic characteristics of images and microscopic pathological indicators.

Interventions

All patients underwent measurement of HVPG under local anesthesia.

Sponsors

The Third People's Hospital of Taiyuan
CollaboratorOTHER
QuFu People's Hospital
CollaboratorINDIV
Shenyang Sixth People's Hospital
CollaboratorOTHER
LanZhou University
CollaboratorOTHER
Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region
CollaboratorUNKNOWN
Fifth Medical Center of Chinese PLA General Hospital
CollaboratorUNKNOWN
Tsinghua University
CollaboratorOTHER
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. age above or equal to 18-year-old; 2. fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations; 3. with HVPG examination in the past 6 months; 4. applied a patented technology based on mobile phone for collecting and analyzing tongue-eye-palm images 5. signed informed consent.

Exclusion criteria

1. contradictions for HVPG examination; 2. accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation); 3. accepted transjugular intrahepatic portosystemic shunt; 4. diagnosed as hepatocellular carcinoma.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the precise evaluation method of traditional Chinese and western medicine for portal hypertension with cirrhosis by combining the macroscopic characteristics of images and microscopic pathological indicators.1 yearIn HVPG (mmHg) as reference method in evaluating portal pressure measured by intervention specialist, to develop a new traditional Chinese and western medicine method based on the macroscopic characteristics of images and microscopic pathological indicators and evaluate the accuracy in diagnosing portal hypertension.

Secondary

MeasureTime frameDescription
Accuracy of the precise evaluation method of traditional Chinese and western medicine for high risk varices with cirrhosis by combining the macroscopic characteristics of images and microscopic pathological indicators.1 yearTo assess the precise evaluation method of traditional Chinese and western medicine to avoid unnecessary endoscopies in patients with cirrhosis.

Countries

China

Contacts

Primary ContactXiaolong Qi, M.D.
qixiaolong@vip.163.com+8618588602600
Backup ContactChuan Liu, MD
845424585@qq.com+8615626415443

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026