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临床试验/NCT07116096
NCT07116096招募中不适用

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

Shanxi Provincial People's Hospital4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
4
主要终点
portal pressure

研究概览

简要总结

  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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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.

研究组 & 干预措施

Portal pressure measurement group

Experimental

干预措施: Jamar Hand Dynamometer, Hand Dynamometer (Device)

Doppler Ultrasound Measurement Group

Experimental

干预措施: Jamar Hand Dynamometer, Hand Dynamometer (Device)

Endoscopic Ultrasound Measurement Group

Experimental

干预措施: Jamar Hand Dynamometer, Hand Dynamometer (Device)

结局指标

主要结局

portal pressure

时间窗: through study completion, an average of 3 minutes

portal flow velocity

时间窗: 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

时间窗: 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

时间窗: through study completion, an average of 3 minutes

Blood flow direction of esophageal varices

时间窗: through study completion, an average of 3 minutes

Diameter of esophageal varices

时间窗: through study completion, an average of 3 minutes

left gastric vein pressure

时间窗: through study completion, an average of 3 minutes

Heart rate

时间窗: through study completion, an average of 3 minutes

blood pressure

时间窗: through study completion, an average of 3 minutes

次要结局

  • Fasting blood glucose(Baseline)
  • Serum creatinine(Baseline)
  • Serum albumin(Baseline)
  • Prothrombin time(Baseline)
  • triglyceride(Baseline)
  • Total cholesterol(Baseline)
  • Platelet count(Baseline)
  • Serum potassium(Baseline)
  • Serum sodium(Baseline)
  • Serum chloride(Baseline)
  • alanine aminotransferase(Baseline)
  • aspartate aminotransferase(Baseline)
  • Total bilirubin(Baseline)
  • height(Baseline)
  • weight(Baseline)

研究者

发起方
Shanxi Provincial People's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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