The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

NCT ID: NCT04786782

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2023-09-30

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.

Conditions

Portal Hypertension; Cirrhosis, Liver

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Three-dimensional reconstruction group

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

PPG-detecting software

Intervention Type: DIAGNOSTIC_TEST

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.

Natural follow-up group

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

LSM and PLT count

Intervention Type: DIAGNOSTIC_TEST

Patients whose LSM \>15kPa, or PLT count \< 150\*10\^9 should be screened with upper GI endoscopy

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

LSM and PLT count

Patients whose LSM \>15kPa, or PLT count \< 150\*10\^9 should be screened with upper GI endoscopy

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changqing Yang

OTHER

Sponsor Role: lead

Responsible Party

Changqing Yang

Principal Investigator,Head of Gastroenterology and Hepatology, Chief Physician, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

Yang-20210205

Identifier Type: -

Identifier Source: org_study_id