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Ultrasound Assessment of Diaphragmatic Structure and Function in Patients With Liver Cirrhosis: A Point-of-Care Tool for Predicting Complications and Sarcopenia in Limited Resource Settings

2026年6月19日 更新者：Nada Refaat Mohamed Abdelshafy Samasiri、Assiut University

The goal of this observational study is to learn how liver cirrhosis affects the diaphragm, the main muscle used for breathing, in adults. The study will measure diaphragmatic thickness, thickening fraction, and excursion using bedside ultrasound and compare these values between patients with cirrhosis and healthy volunteers. The main questions it aims to answer are:

Do patients with cirrhosis show reduced diaphragmatic function compared to healthy adults?

Does removal of ascitic fluid by paracentesis improve diaphragmatic mechanics?

Can ultrasound measurements of the diaphragm serve as a reliable non-invasive marker of sarcopenia when compared to CT scans?

Participants will:

Undergo diaphragmatic ultrasound during quiet and deep breathing

Provide clinical and laboratory data related to liver disease severity

In some cases, have ultrasound repeated before and after paracentesis

For patients with hepatocellular carcinoma, CT scans will be analyzed to measure muscle mass

調査の概要

状態

まだ募集していません

条件

詳細な説明

This study is a prospective observational cohort designed to evaluate diaphragmatic structure and function in adults with liver cirrhosis. Using bedside ultrasound, the study will measure diaphragmatic thickness, thickening fraction, and excursion, and compare these values across different stages of liver disease severity and complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup of patients undergoing large-volume paracentesis will have ultrasound assessments before and after fluid removal to determine the acute impact of ascites drainage on diaphragmatic mechanics. In patients with hepatocellular carcinoma, existing CT scans will be analyzed to calculate skeletal muscle index, allowing correlation between ultrasound parameters and sarcopenia. Healthy volunteers will serve as a reference group for establishing normative values. Clinical and laboratory data, respiratory outcomes, and hospitalization details will also be collected to explore associations between diaphragmatic dysfunction and patient prognosis. The study aims to validate diaphragmatic ultrasound as a simple, non-invasive tool for respiratory monitoring and sarcopenia assessment in cirrhosis, particularly in resource-limited settings.

研究の種類

観察的

入学 (推定)

120

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Mohamed Abdelghany Abdelhamed
  • 電話番号：+201112828724
  • メール：Moh7111@aun.edu.eg

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Adults (≥18 years of age) with confirmed diagnosis of liver cirrhosis attending the hepatology outpatient clinic or admitted to the hepatology inpatient unit of the study institution.

Study Subgroups The total study sample will consist of 120 participants, including 95 patients with liver cirrhosis and 25 healthy controls. The cirrhotic cohort will include patients across different Child-Pugh classes and MELD scores and will encompass clinically relevant subgroups such as patients with ascites undergoing paracentesis, hepatic hydrothorax, and hepatocellular carcinoma (HCC).

  • Subgroup A: Ascites/Paracentesis (n=30): Patients with tense or refractory ascites for whom large-volume paracentesis is clinically indicated. This subgroup will contribute both cross-sectional and longitudinal (pre/post paracentesis) data.
  • Subgroup B: Hepatic Hydrothorax (n=40): Twenty patients with confirmed hepatic hydrothorax (HH; defined as pleural effusion >500 mL in the absence of primary cardiopulm

説明

Inclusion Criteria:

  1. Age ≥18 years.
  2. Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, histological, or imaging criteria.
  3. Ability to provide written informed consent in Arabic or English.
  4. For Subgroup A: clinical indication for large-volume paracentesis with an ascitic volume of ≥5 liters.
  5. For Subgroup B: confirmed hepatic hydrothorax or confirmed absence of pleural effusion on ultrasound or chest X-ray.
  6. For Subgroup C: radiologically confirmed HCC by triphasic CT or MRI according to EASL/AASLD diagnostic criteria, with available CT imaging for L3 SMI analysis.

Exclusion Criteria:

  1. Significant pre-existing primary pulmonary disease (e.g., moderate-to-severe COPD defined as FEV1/FVC <70% with FEV1 <60% predicted, interstitial lung disease, pulmonary fibrosis) that independently affects diaphragmatic mechanics.
  2. Recent thoracic surgery, thoracocentesis within the preceding 72 hours, or thoracic trauma.
  3. Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, Guillain-Barré syndrome) independently affecting diaphragmatic function.
  4. Active mechanical ventilation at time of enrollment.
  5. Pregnancy.
  6. Inability to achieve adequate ultrasound acoustic windows (e.g., due to extreme obesity or surgical dressings).
  7. Contraindications to paracentesis in Subgroup A (e.g., disseminated intravascular coagulation, bowel obstruction).
  8. Prior or planned liver transplantation within the study period, which would confound longitudinal follow-up.
  9. Refusal or inability to provide informed consent.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Adults with Liver Cirrhosis
This cohort includes adults diagnosed with liver cirrhosis, with subgroups defined by complications such as ascites, hepatic hydrothorax, and hepatocellular carcinoma. A subgroup undergoing paracentesis will be assessed before and after fluid removal to evaluate acute changes in diaphragmatic function. In patients with hepatocellular carcinoma, CT scans will be analyzed to calculate skeletal muscle index for correlation with ultrasound findings. A small number of healthy volunteers will also undergo diaphragmatic ultrasound to establish normative reference values; however, they are not considered a separate cohort for analysis.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Diaphragmatic Thickness (Tdi-exp, Tdi-insp) [cm]
時間枠：Baseline (Day 1, at enrollment).
Diaphragmatic thickness at end-expiration (Tdi-exp) and end-inspiration (Tdi-insp) measured by B-mode ultrasound.
Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction (TF) [%]
時間枠：Baseline (Day 1, at enrollment).
Thickening fraction calculated as [(Tdi-insp - Tdi-exp) / Tdi-exp] × 100, measured by B-mode ultrasound.
Baseline (Day 1, at enrollment).
Diaphragmatic Excursion (DE) [cm]
時間枠：Baseline (Day 1, at enrollment).
Amplitude of diaphragmatic displacement measured by M-mode ultrasound during quiet breathing.
Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Thickness Across Cirrhosis Stages
時間枠：Baseline (Day 1, at enrollment)

Mean differences in diaphragmatic thickness (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.

Unit of Measure: Mean difference (cm).
Baseline (Day 1, at enrollment)
Group Differences in Diaphragmatic Thickening Fraction Across Cirrhosis Stages
時間枠：Baseline (Day 1, at enrollment).

Mean differences in diaphragmatic thickening fraction (%) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.

Unit of Measure: Mean difference (%).
Baseline (Day 1, at enrollment).
Group Differences in Diaphragmatic Excursion Across Cirrhosis Stages
時間枠：Baseline (Day 1, at enrollment).

Mean differences in diaphragmatic excursion (cm) between patients with Child-Pugh A, B, and C cirrhosis, and across MELD score strata.

Unit of Measure: Mean difference (cm).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickness with Disease Severity
時間枠：Baseline (Day 1, at enrollment).

Correlation between diaphragmatic thickness (cm) and liver disease severity scores (Child-Pugh class, MELD score).

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Thickening Fraction (TF) with Disease Severity
時間枠：Baseline (Day 1, at enrollment).

Correlation between diaphragmatic thickening fraction (%) and liver disease severity scores (Child-Pugh class, MELD score).

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Excursion (DE) with Disease Severity
時間枠：Baseline (Day 1, at enrollment).

Correlation between diaphragmatic excursion (cm) and liver disease severity scores (Child-Pugh class, MELD score).

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).

二次結果の測定

結果測定
メジャーの説明
時間枠
Correlation between diaphragmatic ultrasound parameters and skeletal muscle index (CT scans)
時間枠：At baseline (single measurement)
In patients with hepatocellular carcinoma, triphasic CT scans will be analyzed to calculate skeletal muscle index. These values will be correlated with diaphragmatic ultrasound parameters to assess the utility of ultrasound as a surrogate marker of sarcopenia.
At baseline (single measurement)
Change in Diaphragmatic Thickness After Paracentesis
時間枠：Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.

Change in diaphragmatic thickness (cm) measured by B-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis.

Unit of Measure: Mean difference (cm).
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Thickening Fraction After Paracentesis
時間枠：Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.

Change in diaphragmatic thickening fraction (%) measured by B-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis.

Unit of Measure: Mean difference (%).
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Change in Diaphragmatic Excursion After Paracentesis
時間枠：Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.

Change in diaphragmatic excursion (cm) measured by M-mode ultrasound before and within 60 ± 15 minutes after large-volume paracentesis.

Unit of Measure: Mean difference (cm).
Pre-paracentesis (Day 1, immediately before procedure) and within 60 minutes post-paracentesis.
Diaphragmatic Thickness in Patients With vs. Without Hepatic Hydrothorax
時間枠：Baseline (Day 1, at enrollment).

Comparison of mean diaphragmatic thickness (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.

Unit of Measure: Mean difference (cm).
Baseline (Day 1, at enrollment).
Diaphragmatic Thickening Fraction in Patients With vs. Without Hepatic Hydrothorax
時間枠：Baseline (Day 1, at enrollment).

Comparison of mean diaphragmatic thickening fraction (%) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.

Unit of Measure: Mean difference (%).
Baseline (Day 1, at enrollment).
Diaphragmatic Excursion in Patients With vs. Without Hepatic Hydrothorax
時間枠：Baseline (Day 1, at enrollment).

Comparison of mean diaphragmatic excursion (cm) between cirrhotic patients with hepatic hydrothorax and matched cirrhotic controls without hydrothorax.

Unit of Measure: Mean difference (cm).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Dyspnea Score
時間枠：Baseline (Day 1, at enrollment).

Correlation between diaphragmatic dysfunction (defined by ultrasound parameters) and dyspnea severity measured by the mMRC scale (0-4).

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Respiratory Rate
時間枠：Baseline (Day 1, at enrollment).

Correlation between diaphragmatic dysfunction and respiratory rate (breaths/min).

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Oxygen Saturation
時間枠：Baseline (Day 1, at enrollment).

Correlation between diaphragmatic dysfunction and peripheral oxygen saturation (SpO₂, %).

Unit of Measure: Correlation coefficient (r).
Baseline (Day 1, at enrollment).
Correlation of Diaphragmatic Dysfunction with Length of Hospital Stay
時間枠：During hospitalization (up to 30 days).
Correlation between diaphragmatic dysfunction (defined by ultrasound parameters: thickness, thickening fraction, excursion) and length of hospital stay (days). Unit of Measure: Correlation coefficient (r).
During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with ICU Admission
時間枠：During hospitalization (up to 30 days).
Correlation between diaphragmatic dysfunction and need for ICU admission. Unit of Measure: Odds ratio (% of patients requiring ICU admission).
During hospitalization (up to 30 days).
Correlation of Diaphragmatic Dysfunction with In-Hospital Complications
時間枠：During hospitalization (up to 30 days).
Correlation between diaphragmatic dysfunction and occurrence of complications (e.g., respiratory failure, infection). Unit of Measure: Incidence (% of patients with complications).
During hospitalization (up to 30 days).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assiut University

捜査官

  • 主任研究者：Ahmed Helmy Salem, professor、Assiut University
  • 主任研究者：Maiada Kamal Eldeen Hashem、Assiut University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月10日

一次修了 (推定)

2027年8月10日

研究の完了 (推定)

2027年12月10日

試験登録日

最初に提出

2026年6月16日

QC基準を満たした最初の提出物

2026年6月19日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • DiaphragmCirrhosis_AU26

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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