Portal HypertensionNCT05402410
An AI Model Based on Smartphone-derived Multimodality Images to Evaluate Portal Hypertension in Patients With Cirrhosis (CHESS2203)
An observational study of Portal Hypertension, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Hepatic venous pressure gradient
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients was fulfilled the diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations.
Who may be able to join
- age above or equal to 18-year-old;
- fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations;
- with HVPG examination in the past 6 months;
- applied a patented technology based on mobile phone for collecting and analyzing tongue-eye-palm images
- signed informed consent.
Who cannot join
- contradictions for HVPG examination;
- accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation);
- accepted transjugular intrahepatic portosystemic shunt;
- diagnosed as hepatocellular carcinoma.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
CHESS
Beijing, Beijing Municipality, 1000000
Xiaolong Qi, Prof
- Not yet recruiting
Institute for TCM-X, MOE Key Laboratory of Bioinformatics/Bioinformatics Division, BNRIST, Department of Automation, Tsinghua University
Beijing, Beijing Municipality, 100000
Shao Li, Prof
About this study
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.
Read the 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.
- Conditions
- Portal Hypertension
- Being tested
- Hepatic venous pressure gradient
- Keywords
- cirrhosis, Traditional Chinese Medicine, artificial intelligence, portal hypertension, hepatic venous pressure gradient
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic venous pressure gradientDiagnostic test
All patients underwent measurement of HVPG under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations. Receives: Diagnostic Test: Hepatic venous pressure gradient | |
| Validation cohort | Patients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations. Receives: Diagnostic Test: Hepatic venous pressure gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
In 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.
Measured: 1 year
Secondary outcomes (1)
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.
To assess the precise evaluation method of traditional Chinese and western medicine to avoid unnecessary endoscopies in patients with cirrhosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Collaborators
- The Third People's Hospital of Taiyuan, QuFu People's Hospital, Shenyang Sixth People's Hospital, LanZhou University, Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region, Beijing 302 Hospital, Tsinghua University
- Responsible party
- Principal investigator, Xiaolong Qi, Center for Health Enhancement System Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402410
- Sponsor's protocol ID
- CHESS2203
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PubMed 30215362Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
PubMed 27786365Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
PubMed 27639071Pons M, Augustin S, Scheiner B, Guillaume M, Rosselli M, Rodrigues SG, Stefanescu H, Ma MM, Mandorfer M, Mergeay-Fabre M, Procopet B, Schwabl P, Ferlitsch A, Semmler G, Berzigotti A, Tsochatzis E, Bureau C, Reiberger T, Bosch J, Abraldes JG, Genesca J. Noninvasive Diagnosis of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease. Am J Gastroenterol. 2021 Apr;116(4):723-732. doi: 10.14309/ajg.0000000000000994.
PubMed 33982942de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
PubMed 35120736Xiao W, Huang X, Wang JH, Lin DR, Zhu Y, Chen C, Yang YH, Xiao J, Zhao LQ, Li JO, Cheung CY, Mise Y, Guo ZY, Du YF, Chen BB, Hu JX, Zhang K, Lin XS, Wen W, Liu YZ, Chen WR, Zhong YS, Lin HT. Screening and identifying hepatobiliary diseases through deep learning using ocular images: a prospective, multicentre study. Lancet Digit Health. 2021 Feb;3(2):e88-e97. doi: 10.1016/S2589-7500(20)30288-0.
PubMed 33509389
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An AI Model Based on Smartphone-derived Multimodality Images to Evaluate Portal Hypertension in Patients With Cirrhosis (CHESS2203)
- ClinicalTrials.gov ID
- NCT05402410
- Acronym / sponsor ID
- CHESS2203
- Conditions
- Portal Hypertension
- Keywords
- cirrhosis, Traditional Chinese Medicine, artificial intelligence, portal hypertension, hepatic venous pressure gradient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Collaborators
- The Third People's Hospital of Taiyuan, QuFu People's Hospital, Shenyang Sixth People's Hospital, LanZhou University, Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region, Beijing 302 Hospital, Tsinghua University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Diagnostic Test: Hepatic venous pressure gradientPatients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations. |
| Validation cohort | – | Diagnostic Test: Hepatic venous pressure gradientPatients were fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients was fulfilled the diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations.
Key inclusion criteria (5 listed)
- age above or equal to 18-year-old;
- fulfilled diagnosis of cirrhosis based on radiological, histological features of liver cirrhosis and clinical manifestations;
- with HVPG examination in the past 6 months;
- applied a patented technology based on mobile phone for collecting and analyzing tongue-eye-palm images
- signed informed consent.
Key exclusion criteria (4 listed)
- contradictions for HVPG examination;
- accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation);
- accepted transjugular intrahepatic portosystemic shunt;
- diagnosed as hepatocellular carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic venous pressure gradientAll patients underwent measurement of HVPG under local anesthesia. | Diagnostic test | Training cohort, Validation cohort |
Primary outcome
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.
Time frame: 1 year
In 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.
1 secondary outcome
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.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 30215362Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
- Background: PubMed 27786365Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
- Background: PubMed 27639071Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
- Background: PubMed 33982942Pons M, Augustin S, Scheiner B, Guillaume M, Rosselli M, Rodrigues SG, Stefanescu H, Ma MM, Mandorfer M, Mergeay-Fabre M, Procopet B, Schwabl P, Ferlitsch A, Semmler G, Berzigotti A, Tsochatzis E, Bureau C, Reiberger T, Bosch J, Abraldes JG, Genesca J. Noninvasive Diagnosis of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease. Am J Gastroenterol. 2021 Apr;116(4):723-732. doi: 10.14309/ajg.0000000000000994.
- Background: PubMed 35120736de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Background: PubMed 33509389Xiao W, Huang X, Wang JH, Lin DR, Zhu Y, Chen C, Yang YH, Xiao J, Zhao LQ, Li JO, Cheung CY, Mise Y, Guo ZY, Du YF, Chen BB, Hu JX, Zhang K, Lin XS, Wen W, Liu YZ, Chen WR, Zhong YS, Lin HT. Screening and identifying hepatobiliary diseases through deep learning using ocular images: a prospective, multicentre study. Lancet Digit Health. 2021 Feb;3(2):e88-e97. doi: 10.1016/S2589-7500(20)30288-0.
- Individual participant dataSharing planned: Undecided
Related trials for Portal Hypertension
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 4
Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
Portal Hypertension, Hepatic Decompensation
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruiting
"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Qi, M.D. (+8618588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402410, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.