Clinical trial NCT04786782: The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Portal Hypertension
Cirrhosis, Liver
Keywords: Virtual portal pressure gradient
Enhanced upper abdominal CT
Portal ultrasound
Portal hypertension
Cirrhosis
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed cirrhosis by imaging tests (upper abdominal ultrasound/CT /MRI) or liver biopsy pathology

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.


Eligibility criteria: 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

Primary outcomes:
measure: The morbidity of cirrhotic decompensated events
timeFrame: 2 years
measure: The mortality of cirrhosis
timeFrame: 2 years
Secondary outcomes:
measure: Spared endoscopies
timeFrame: 2 years
measure: Number of missed VNT
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
Study officials:
References: