Effect of Handgrip Strength on Portal Vein Hemodynamics in Patients With Liver Cirrhosis

Обзор

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, as well as its hemodynamic impact on gastroesophageal varices. 3. Method Study Design: Interventional study. Detection Timing: Hemodynamic indices were measured simultaneously after patients achieved their maximum handgrip strength. Participants were divided into three groups based on the assessment methods. Group 1 (Portal Pressure Measurement Group): Before the placement of TIPS, the pressures of the portal vein and left gastric vein were measured, both before and after the handgrip strength test. Group 2 (Doppler Ultrasound Measurement Group): Measurements of portal flow velocity and direction were taken before and after the handgrip strength test, based on Doppler ultrasound. Group 3 (Endoscopic Ultrasound Measurement Group): Measurements of blood flow volume and direction in esophagogastric varices were conducted before and after the handgrip strength test, based on endoscopic ultrasonography. The inclusion and exclusion criteria were described. 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. Effects on varicose veins: Improved handgrip strength may reduce blood flow velocity or diameter of esophagogastric varices by decreasing splanchnic congestion or regulating local vascular tension, thus lowering the risk of variceal rupture and bleeding. Role of compensatory mechanisms: Muscle wasting is common in decompensated cirrhosis. Patients with higher handgrip strength may have better compensatory capacity, and the degree of hemodynamic disorder in their portal venous system may be less severe. Conclusion This study uses a multi-method grouping design to first explore the association between handgrip strength and portal venous hemodynamics in cirrhotic patients. The hypothesis is based on the potential regulatory role of muscle function in the circulatory system, which is expected to provide a new non-invasive indicator for clinical assessment of portal hypertension risk.

Вмешательства

• Устройство Jamar Hand Dynamometer, Hand Dynamometer
  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

Первичные конечные точки

• portal pressure [Срок оценки: through study completion, an average of 3 minutes]
• left gastric vein pressure [Срок оценки: through study completion, an average of 3 minutes]
• portal flow velocity [Срок оценки: Before the handgrip strength test, and during the maximum 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 HGS]
• Portal vein blood flow direction [Срок оценки: Before the handgrip strength test, and during the maximum 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 HGS]
• Blood flow velocity in esophageal varices [Срок оценки: through study completion, an average of 3 minutes]
• Blood flow direction of esophageal varices [Срок оценки: through study completion, an average of 3 minutes]
• Diameter of esophageal varices [Срок оценки: through study completion, an average of 3 minutes]
• Heart rate [Срок оценки: through study completion, an average of 3 minutes]
• blood pressure [Срок оценки: through study completion, an average of 3 minutes]

Вторичные конечные точки (12)

• Serum albumin [Срок оценки: Baseline]
• Prothrombin time [Срок оценки: Baseline]
• triglyceride [Срок оценки: Baseline]
• Total cholesterol [Срок оценки: Baseline]
• Fasting blood glucose [Срок оценки: Baseline]
• Serum creatinine [Срок оценки: Baseline]
• Platelet count [Срок оценки: Baseline]
• Serum potassium [Срок оценки: Baseline]
• Serum sodium [Срок оценки: Baseline]
• Serum chloride [Срок оценки: Baseline]
• alanine aminotransferase [Срок оценки: Baseline]
• aspartate aminotransferase [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• Shanxi Provincial People's Hospital — Taiyuan

Идентификаторы

NCT: NCT07116096 · MZhao

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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