Handgrip strength and portal vein blood flow in people with liver cirrhosis
Effect of Handgrip Strength on Portal Vein Hemodynamics in Patients With Liver Cirrhosis
This trial will test whether squeezing a handgrip changes portal vein and left gastric vein pressures and blood flow in adults with liver cirrhosis to see if muscle strength affects variceal hemodynamics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanxi Provincial People's Hospital Government |
| Locations | 2 sites (Luoyang, Henan and 1 other locations) |
| Trial ID | NCT07116096 on ClinicalTrials.gov |
What this trial studies
Researchers will use a hand dynamometer to measure maximum handgrip strength and simultaneously record portal and left gastric vein pressures, flow velocity, and flow direction. Participants are divided into three assessment groups: direct portal pressure measurement during TIPS placement, Doppler ultrasound measurement, and endoscopic ultrasound measurement. Hemodynamic indices are recorded before and immediately after the handgrip maneuver to compare changes. The study targets correlations between a simple muscle-strength test and acute changes in portal-systemic blood flow that relate to gastroesophageal varices.
Who should consider this trial
Good fit: Adults (≥18 years) with clinically diagnosed liver cirrhosis and endoscopically characterized esophagogastric varices who can perform a maximal handgrip and give informed consent are ideal candidates.
Not a fit: Patients with severe cardiac or pulmonary disease, uncontrolled infection, high MELD/Child-Pugh scores beyond inclusion limits, active uncontrollable bleeding, or other exclusion criteria are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a simple bedside maneuver to reveal changes in portal hemodynamics that help predict or manage variceal risk in cirrhosis patients.
How similar studies have performed: Handgrip strength has been linked to prognosis in cirrhosis, but using it to provoke and measure portal venous hemodynamic changes is a novel and largely untested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥18 years old * Clinically diagnosed with liver cirrhosis * Endoscopic observation to determine the presence of esophagogastric varices * Only eligible for the portal vein pressure measurement group if there are no signs of variceal bleeding for at least 14 days * Participant or guardian is capable of comprehending the study protocol, willing to participate, and able to provide written informed consent Exclusion Criteria: * Severe congestive heart failure, or severe untreated valvular heart disease * Moderate to severe pulmonary hypertension * Uncontrolled systemic infection * Lesions (e.g., cysts) or tumors in the liver parenchyma that preclude TIPS creation * Overt hepatic encephalopathy * Unrelieved biliary obstruction * Child-Pugh score \> 13 * MELD score \> 18 * INR \> 5 * Platelet count \< 20 ×109/mm3 * No gastrointestinal bleeding (suitable for the ultrasound examination group and the endoscopic ultrasonography group) * Participants who had undergone hand or wrist surgery within the previous 3 months or were unable to hold the dynamometer with the testing hand were excluded from the study.
Where this trial is running
Luoyang, Henan and 1 other locations
- The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
- Shanxi Provincial People's Hospital — Taiyuan, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Mingyuan Zhao, M.D.
- Email: zmy255255@163.com
- Phone: +86 134 8537 1098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.