Handgrip Strength Increases the Pressure in the Portal and Left Gastric Veins in Cirrhotic Patients

NCT07289698 | Recruiting

• 1 other identifier: MZ
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

1.Background Handgrip strength , a core indicator of muscle function, has been confirmed to be significantly associated with the clinical prognosis of patients with liver cirrhosis. However, no studies have explored its correlation with portal venous hemodynamics. 2. Objective The purpose of the study is to examine the effects of Handgrip strength on portal vein and left gastric vein pressure, blood flow velocity and direction in patients with liver cirrhosis. 3\. Method: observational study. Detection Timing: Doppler ultrasound was employed to determine the portal flow velocity and direction at baseline and during the handgrip strength test in cirrhotic patients with a history of variceal bleeding. Three days later, prior to TIPS placement, the pressures in the portal pressure and gastric vein pressure were measured both before and after handgrip strength. Furthermore, carvedilol and vasoactive drugs were discontinued three days before the study commenced. 4. Elaboration of the Research Hypothesis 4.1. Core Hypothesis The handgrip strength level in patients with liver cirrhosis is correlated with portal venous system hemodynamic indices. Specifically, enhanced handgrip strength may affect portal hypertension and the hemodynamics of varicose veins by improving systemic muscle function or circulatory status. 4.2. Speculation on potential mechanisms Association between muscle function and circulation: As a representative of systemic muscle function, increased handgrip strength may reflect an increase in cardiac output or changes in splanchnic vascular resistance, thereby influencing portal venous hemodynamics.

Conditions

Transjugular Intrahepatic Portosystemic Shunts (TIPS); Handgrip Strength

Outcome Measures

Primary Outcomes (4)

• portal pressure

  Prior to TIPS, the pressure monitoring catheter was connected to the pressure-measuring device. Subsequently, the pressures in both the portal vein and left gastric vein were measured simultaneously at baseline and during the handgrip strength test.

  through study completion, an average of 5 minutes

• left gastric vein pressure

  Prior to TIPS, the pressure monitoring catheter was connected to the pressure-measuring device. Subsequently, the pressures in both the portal vein and left gastric vein were measured simultaneously at baseline and during the handgrip strength test.

  through study completion, an average of 5 minutes

• portal flow velocity

  At least 72 hours after the baseline handgrip strength and during the handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the handgrip Strength

• Portal vein blood flow direction

  At least 72 hours after the baseline handgrip strength and during the handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the handgrip Strength

Secondary Outcomes (25)

• Serum albumin (g / l)

  Baseline

• alanine aminotransferase(IU / L)

  Baseline

• aspartate aminotransferase (IU / L)

  Baseline

• Total bilirubin (µmol / l)

  Baseline

• Prothrombin time (second)

  Baseline

Study Arms (2)

Portal pressure measurement group

Device: Handgrip strength

Doppler Ultrasound Measurement Group

Device: Handgrip strength

Interventions

Handgrip strength DEVICE

Jamar Hand Dynamometer, from Illinois, USA. Maximum handgrip strength was measured three times, with each measurement lasting 3 seconds and a 1-minute interval between tests

Doppler Ultrasound Measurement Group; Portal pressure measurement group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational study was performed in two centers in China (The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology \[Luoyang\], and Shanxi Provincial People's Hospital \[Taiyuan\]) . They serve as the major tertiary referral center for the management of liver cirrhosis and its complications in our country.

You may qualify if:

• adult patients (≥18 years of age) with cirrhosis and a history of variceal bleeding, who were preparing for TIPS creation for secondary prophylaxis against variceal bleeding

You may not qualify if:

• 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
• Model for end-stage liver disease (MELD) score \> 18
• International normalized ratio (INR) \> 5
• Platelet count \< 20×109/mm3
• 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.

Sponsors & Collaborators

• Shanxi Provincial People's Hospital: lead
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator

Study Sites (2)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

NOT YET RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

RECRUITING

Central Study Contacts

Mingyuan Zhao, M.D.

CONTACT

+86 134 8537 1098; zmy255255@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 31, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Sharing and email consultation will begin after December 31, 2027

Locations

CN (2)