The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

Active, not recruiting

• Conditions: Portal Hypertension; Cirrhosis, Liver
• Interventions: Diagnostic Test: PPG-detecting software; Diagnostic Test: LSM and PLT count

• Registration Number: NCT04786782
• Lead Sponsor: Changqing Yang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-02
• Study Start: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Three-dimensional reconstruction group	PPG-detecting software	Portal hypertension is controlled with upper endoscopic screening and vPPG was detected by the noninvasive PPG-detecting software
Natural follow-up group	LSM and PLT count	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

Primary Outcome Measures

Name	Time	Method
The morbidity of cirrhotic decompensated events	2 years	The occurence rate of cirrhotic decompensated events of enrolled patients
The mortality of cirrhosis	2 years	Patients who die because of cirrhosis

Secondary Outcome Measures

Name	Time	Method
Spared endoscopies	2 years	Patients who don't need upper endoscopic monitoring
Number of missed VNT	2 years	Missed cases of patients who have varices needing treatment

Trial Locations

Locations (1)

Shanghai Tongji Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China