The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

Changqing Yang

Status: Active, not recruiting

Conditions: Portal Hypertension; Cirrhosis, Liver

Treatments: Diagnostic Test: PPG-detecting software; Diagnostic Test: LSM and PLT count

Study type: Observational

Funder types: Other

Identifiers

NCT04786782

Yang-20210205

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Three-dimensional reconstruction group

Description:

Portal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software

Treatment:

Diagnostic Test: PPG-detecting software

Natural follow-up group

Description:

Portal hypertension is controlled with the most updated guideline for clinical practice, namely, cirrhotic patients with either liver stiffness measurement \>15kPa or PLT\<150\*10\^9 should be screened with upper GI endoscopy and treated according to endoscopic results

Treatment:

Diagnostic Test: LSM and PLT count