このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Diaphragm Kinetics Following Hepatic Resection

2021年5月11日 更新者:Gregory van der Kroft、RWTH Aachen University

Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.

Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function.

Hypotheses:

  • Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function.
  • Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection.

Goals:

The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients.

Methods and analysis:

Trans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.

調査の概要

研究の種類

観察的

入学 (予想される)

44

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

研究場所

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

18年~85年 (大人、高齢者)

健康ボランティアの受け入れ

なし

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

This study will entail a prospective observational single center study, analyzing 44 consecutive patients undergoing major liver resection, 22 patients will be sarcopenic, 22 will be non-sarcopenic

説明

Inclusion Criteria:

  • Patients between 18- and 80 years old
  • Patients undergoing elective Major hepatic resection for the treatment of malignant disease.
  • Patients with all tumor Stages (TNM classification).
  • Only patients undergoing Major hepatic resection.

Exclusion Criteria:

  • American Anesthesiology Association (ASA)-classification IV or higher
  • Liver cirrhosis Child grade B or higher
  • End stage renal disease requiring dialysis
  • Severe heart disease New York Heart Association class IV
  • Pulmonary condition:

    • Chronic obstructive pulmonary disease (COPD)
    • Asthma
    • History of pulmonary surgery
    • History of pulmonary embolism
    • Smoking
    • Pleural effusion occupying more than 1/3 of the pleural space
  • Neurological disorders leading to paraparesis of the upper or lower limbs
  • Known muscular dystrophic disorders

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
介入・治療
Sarcopenia
Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP)
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed
No Sarcopenia
Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP)
All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed

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
Diaphragm kinetics
時間枠:Day 1

Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following outcome value.

-Deformation%

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1
Diaphragm kinetics
時間枠:Day 1

Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1
Diaphragm kinetics
時間枠:Day 1

Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Fractional thickening (thickening coefficient)

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1
Diaphragm kinetics
時間枠:Day 1

Comparing diaphragm and abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Range of DIA (in cm)

Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1
Abdominal muscle kinetics
時間枠:Day 1

Primary outcome:

Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Thickness (in cm)

Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1
Abdominal muscle kinetics
時間枠:Day 1

Primary outcome:

Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation%

Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1
Abdominal muscle kinetics
時間枠:Day 1

Primary outcome:

Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)

Day 1

二次結果の測定

結果測定
メジャーの説明
時間枠
Diaphragm kinetics
時間枠:30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Deformation%

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

30 days
Diaphragm kinetics
時間枠:30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

30 days
Diaphragm kinetics
時間枠:30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Fractional thickening (thickening coefficient)

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

30 days
Diaphragm kinetics
時間枠:30 days

Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Diaphragm muscle kinetics will be evaluated using the following value.

-Range of DIA (in cm)

Differences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

30 days
Abdominal muscle kinetics
時間枠:30 days

Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Thickness (in cm)

Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

30 days
Abdominal muscle kinetics
時間枠:30 days

Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation%

Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

30 days
Abdominal muscle kinetics
時間枠:30 days

Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.

Abdominal muscle kinetics will be evaluated using the following value.

-Deformation velocity (in cm/second)

Differences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).

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

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 (実際)

2020年4月1日

一次修了 (予想される)

2022年5月1日

研究の完了 (予想される)

2022年11月1日

試験登録日

最初に提出

2020年10月21日

QC基準を満たした最初の提出物

2021年5月11日

最初の投稿 (実際)

2021年5月17日

学習記録の更新

投稿された最後の更新 (実際)

2021年5月17日

QC基準を満たした最後の更新が送信されました

2021年5月11日

最終確認日

2021年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する