The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

Portal Hypertension Clinical Trial

Official title:

Clinical Management of Patients With Cirrhotic Portal Hypertension Based on the Noninvasive Portal Pressure Gradient (vPPG) Detecting Software, a Prospective and Controlled Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04786782
• Other study ID #: Yang-20210205
• Status: Active, not recruiting
• Start date: March 3, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2023
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the possibilities and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. In this study, the three-dimensional reconstruction and natural follow-up methods have been respectively applied in the experimental (1st) and active comparator (2nd) group. The virtual PPG is calculated with anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. Cirrhosis patients in the 1st group, with calculated vPPG values, are managed with upper GI endoscopic results. Besides, patients in the 2nd group, are managed according to the most updated Chinese clinical guideline for cirrhotic portal hypertension, namely, patients with either liver stiffness measurement (LSM) >15kPa or PLT count <150*10^9 should be screened and treated with upper GI endoscopy. The morbidity of decompensated cirrhotic events and mortality of patients in two arms will be compared. The cutoff values of vPPG to spare endoscopies with low missed VNT (varices needing treatment) are preliminarily determined with the cohort data.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.

Exclusion Criteria:

• 1. Portal vein embolism;
• 2. Splenectomy;
• 3. Hepatic encephalopathy;
• 4. Hepatic space occupying lesions (such as hepatic cysts, hemangiomas, etc.) with diameter > 3cm and local compression effect;
• 5. Contraindications of enhanced CT test, such as iodine allergy, peripheral veins are too thin to inject contrast medium;
• 6. Contraindications of upper GI endoscopy

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Diagnostic Test:
• PPG-detecting software
Virtual PPG (vPPG) of patients in experimental group is calculated based on anatomical and hemodynamic information of portal system collected by ultrasound and CT tests.
• LSM and PLT count
Patients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changqing Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The morbidity of cirrhotic decompensated events	The occurence rate of cirrhotic decompensated events of enrolled patients	2 years
Primary	The mortality of cirrhosis	Patients who die because of cirrhosis	2 years
Secondary	Spared endoscopies	Patients who don't need upper endoscopic monitoring	2 years
Secondary	Number of missed VNT	Missed cases of patients who have varices needing treatment	2 years