xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05963776</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-05-02MS</org_study_id>
      <nct_id>NCT05963776</nct_id>
    </id_info>
    <brief_title>Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma</brief_title>
    <official_title>Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cirrhosis is a terminal image of chronic liver disease. During the progression from the&#xD;
        compensation period to the decompensation period, various complications occur, and the life&#xD;
        prognosis is significantly reduced. In recent years, medical treatment for liver cirrhosis&#xD;
        has made marked progress. Liver cirrhosis may occur as an end result of manifold infectious,&#xD;
        toxic, metabolic, or autoimmune conditions such as viral hepatitis, alcoholism, non-alcoholic&#xD;
        steatohepatitis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary&#xD;
        biliary cholangitis (PBC), or a variety of storage disorders such as hemochromatosis,&#xD;
        Wilson's disease, and alpha-1-antitrypsin deficiency.&#xD;
  &#xD;
        Worldwide, hepatocellular carcinoma (HCC) is a universal problem and its epidemiological data&#xD;
        showed variation from place to place. HCC represents the sixth most common cancer worldwide.&#xD;
        In Egypt, it represents the fourth common cancer. Egypt ranks the third and 15th most&#xD;
        populous country in Africa and worldwide, respectively. HCC is a commonly diagnosed cancer in&#xD;
        males and females. It can lead to multi-organ failure including the respiratory system.&#xD;
  &#xD;
        Pulmonary function tests (PFTS) are important as an investigation and monitoring of patients&#xD;
        with respiratory pathology. They provide important information relating to the large and&#xD;
        small airways, the pulmonary parenchyma, and the size and integrity of the pulmonary&#xD;
        capillary bed. Although they do not provide a definite diagnosis, different patterns of&#xD;
        abnormalities are seen in different respiratory diseases which help to establish the&#xD;
        diagnosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cirrhosis is a terminal image of chronic liver disease. During the progression from the&#xD;
        compensation period to the decompensation period, various complications occur, and the life&#xD;
        prognosis is significantly reduced. In recent years, medical treatment for liver cirrhosis&#xD;
        has made marked progress. Liver cirrhosis may occur as an end result of manifold infectious,&#xD;
        toxic, metabolic, or autoimmune conditions such as viral hepatitis, alcoholism, non-alcoholic&#xD;
        steatohepatitis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary&#xD;
        biliary cholangitis (PBC), or a variety of storage disorders such as hemochromatosis,&#xD;
        Wilson's disease, and alpha-1-antitrypsin deficiency .Worldwide, hepatocellular carcinoma&#xD;
        (HCC) is a universal problem and its epidemiological data showed variation from place to&#xD;
        place. HCC represents the sixth most common cancer worldwide. In Egypt, it represents the&#xD;
        fourth common cancer. Egypt ranks the third and 15th most populous country in Africa and&#xD;
        worldwide, respectively. HCC is a commonly diagnosed cancer in males and females. It can lead&#xD;
        to multi-organ failure including the respiratory system.Patients with liver cirrhosis and HCC&#xD;
        are vulnerable to many side effects that reduce their lifetime. One of these side effects is&#xD;
        hypoxia resulting from Many conditions which can influence the gas exchange in the lungs.&#xD;
        Ascites, pleural effusion, hepatomegaly, and basal lung lobes atelectasis are the most&#xD;
        commonly identified causes and can disturb oxygen exchange in a restrictive manner. On the&#xD;
        other hand, some side effects of cirrhosis such as hepatopulmonary syndrome or portopulmonary&#xD;
        hypertension may make the prognosis worse.Pulmonary function tests (PFTS) are important as an&#xD;
        investigation and monitoring of patients with respiratory pathology. They provide important&#xD;
        information relating to the large and small airways, the pulmonary parenchyma, and the size&#xD;
        and integrity of the pulmonary capillary bed. Although they do not provide a definite&#xD;
        diagnosis, different patterns of abnormalities are seen in different respiratory diseases&#xD;
        which help to establish the diagnosis.There is no simple mechanism to explain the association&#xD;
        between liver disease and hypoxemia and there are probably many factors that have a role in&#xD;
        its pathogenesis. Although none of them have been proven as the sole reason, nevertheless&#xD;
        ascites, hepatopulmonary syndrome, low albumin levels, anemia, respiratory muscle weakness,&#xD;
        and extreme hepatomegaly are still considered among the factors implicated in the&#xD;
        pathogenesis of hypoxemia in cirrhosis .Pulmonary complications such as hepatopulmonary&#xD;
        syndrome and pulmonary hypertension are observed frequently in these patients. The clinical&#xD;
        picture characterized by hypoxemia in absence of primary heart and lung diseases in patients&#xD;
        with liver failure is called hepatopulmonary syndrome. In hepatopulmonary syndrome, there is&#xD;
        an increase in the alveolar-arterial oxygen gradient and a concomitant dilatation of the&#xD;
        intrapulmonary vasculature during the inhalation of room air in addition to liver disease.&#xD;
        Varying degrees of pulmonary findings including dyspnea, cyanosis, clubbing, and platypnea&#xD;
        due to dilatations in the intrapulmonary vasculature (increase in dyspnea upon the shift from&#xD;
        lying to standing position) and orthodeoxia (increase in hypoxia upon the shift from lying to&#xD;
        standing position), and hypoxemia are seen in patients with HPS in cirrhotic and HCC&#xD;
        patients.In general, PFT is employed to measure lung volumes, bronchial obstruction, gas&#xD;
        exchange, lung compliance, and ventilatory capacity. Interstitial lung diseases (ILDs) are&#xD;
        characterized by reduced lung volumes (restrictive ventilatory impairment), reduced (static)&#xD;
        lung compliance, and reduced diffusing capacity. The pattern of lung function impairments&#xD;
        does not allow a specific diagnosis to be made, but rather enables one to assess the presence&#xD;
        or absence and the severity of lung involvement. Spirometry is a simple test to measure&#xD;
        static lung volumes at rest-slow (inspiratory or expiratory) vital capacity (SVC), forced&#xD;
        vital capacity (FVC)-and dynamic volumes-forced expiratory volume in 1 s (FEV1), flow-volume&#xD;
        loops&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>pulmonary complications of liver cirrhosior or HCC</measure>
      <time_frame>from 1-9-2023 to 1-9-2024</time_frame>
      <description>assess pulmonary functions impairement and complications due to liver cirrhosis or HCC using spirometer device parameters.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Pulmonary Complications of Liver Cirrhosis and HCC</condition>
    <arm_group>
      <arm_group_label>case</arm_group_label>
      <description>cases are cirrhotic with hepatocellular carcinoma</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <description>patients with cirrhosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>spirometry</intervention_name>
      <description>pulmonary function tests using spirometry</description>
      <arm_group_label>case</arm_group_label>
      <arm_group_label>control</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients diagnosed with liver cirrhosis with and without HCC depending on clinical&#xD;
          evidence of stigmata of liver disease (e.g. jaundice, ascites, palmar erythema, spider&#xD;
          navi, etc), laboratory data and ultra-sonographic features.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients diagnosed with liver cirrhosis with and without HCC depending on&#xD;
               clinical evidence of stigmata of liver disease (e.g. jaundice, ascites, palmar&#xD;
               erythema, spider navi, etc), laboratory data and ultra-sonographic features.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with primary pulmonary pathology.&#xD;
  &#xD;
            -  Coexisting intrinsic heart disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>youssef Mohammed mahmoud, Resident</last_name>
      <phone>01062610036</phone>
      <email>youssefmohamed@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>mahmoud saif Al-Islam, Professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag University hospitals</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Magdy M Amin, Professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.</citation>
      <PMID>29307467</PMID>
    </reference>
    <reference>
      <citation>Fukui H, Saito H, Ueno Y, Uto H, Obara K, Sakaida I, Shibuya A, Seike M, Nagoshi S, Segawa M, Tsubouchi H, Moriwaki H, Kato A, Hashimoto E, Michitaka K, Murawaki T, Sugano K, Watanabe M, Shimosegawa T. Evidence-based clinical practice guidelines for liver cirrhosis 2015. J Gastroenterol. 2016 Jul;51(7):629-50. doi: 10.1007/s00535-016-1216-y. Epub 2016 May 31.</citation>
      <PMID>27246107</PMID>
    </reference>
    <reference>
      <citation>Lima B, Martinelli A, Franca AV. [Hepatopulmonary syndrome: pathogenesis, diagnosis and treatment]. Arq Gastroenterol. 2004 Oct-Dec;41(4):250-8. doi: 10.1590/s0004-28032004000400010. Epub 2005 Mar 29. Portuguese.</citation>
      <PMID>15806270</PMID>
    </reference>
    <reference>
      <citation>Przybylowski T, Krenke R, Fangrat A, Nasilowski J, Grabczak EM, Styczynski G, Pruszczyk P, Krawczyk M, Chazan R. Gas exchange abnormalities in patients listed for liver transplantation. J Physiol Pharmacol. 2006 Sep;57 Suppl 4:313-23.</citation>
      <PMID>17072060</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Youssef Mohamed Mahmoud</investigator_full_name>
      <investigator_title>Resident of Tropical medicine and gastroenterology department, Sohag University Hospitals</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
      <mesh_term>Liver Cirrhosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05963776
  org study id: Soh-Med-23-05-02MS
  nct id: NCT05963776
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cirrhosis is a terminal image of chronic liver disease. During the progression from the
        compensation period to the decompensation period, various complications occur, and the life
        prognosis is significantly reduced. In recent years, medical treatment for liver cirrhosis
        has made marked progress. Liver cirrhosis may occur as an end result of manifold infectious,
        toxic, metabolic, or autoimmune conditions such as viral hepatitis, alcoholism, non-alcoholic
        steatohepatitis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary
        biliary cholangitis (PBC), or a variety of storage disorders such as hemochromatosis,
        Wilson's disease, and alpha-1-antitrypsin deficiency.
  
        Worldwide, hepatocellular carcinoma (HCC) is a universal problem and its epidemiological data
        showed variation from place to place. HCC represents the sixth most common cancer worldwide.
        In Egypt, it represents the fourth common cancer. Egypt ranks the third and 15th most
        populous country in Africa and worldwide, respectively. HCC is a commonly diagnosed cancer in
        males and females. It can lead to multi-organ failure including the respiratory system.
  
        Pulmonary function tests (PFTS) are important as an investigation and monitoring of patients
        with respiratory pathology. They provide important information relating to the large and
        small airways, the pulmonary parenchyma, and the size and integrity of the pulmonary
        capillary bed. Although they do not provide a definite diagnosis, different patterns of
        abnormalities are seen in different respiratory diseases which help to establish the
        diagnosis.
  Cirrhosis is a terminal image of chronic liver disease. During the progression from the
        compensation period to the decompensation period, various complications occur, and the life
        prognosis is significantly reduced. In recent years, medical treatment for liver cirrhosis
        has made marked progress. Liver cirrhosis may occur as an end result of manifold infectious,
        toxic, metabolic, or autoimmune conditions such as viral hepatitis, alcoholism, non-alcoholic
        steatohepatitis, autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary
        biliary cholangitis (PBC), or a variety of storage disorders such as hemochromatosis,
        Wilson's disease, and alpha-1-antitrypsin deficiency .Worldwide, hepatocellular carcinoma
        (HCC) is a universal problem and its epidemiological data showed variation from place to
        place. HCC represents the sixth most common cancer worldwide. In Egypt, it represents the
        fourth common cancer. Egypt ranks the third and 15th most populous country in Africa and
        worldwide, respectively. HCC is a commonly diagnosed cancer in males and females. It can lead
        to multi-organ failure including the respiratory system.Patients with liver cirrhosis and HCC
        are vulnerable to many side effects that reduce their lifetime. One of these side effects is
        hypoxia resulting from Many conditions which can influence the gas exchange in the lungs.
        Ascites, pleural effusion, hepatomegaly, and basal lung lobes atelectasis are the most
        commonly identified causes and can disturb oxygen exchange in a restrictive manner. On the
        other hand, some side effects of cirrhosis such as hepatopulmonary syndrome or portopulmonary
        hypertension may make the prognosis worse.Pulmonary function tests (PFTS) are important as an
        investigation and monitoring of patients with respiratory pathology. They provide important
        information relating to the large and small airways, the pulmonary parenchyma, and the size
        and integrity of the pulmonary capillary bed. Although they do not provide a definite
        diagnosis, different patterns of abnormalities are seen in different respiratory diseases
        which help to establish the diagnosis.There is no simple mechanism to explain the association
        between liver disease and hypoxemia and there are probably many factors that have a role in
        its pathogenesis. Although none of them have been proven as the sole reason, nevertheless
        ascites, hepatopulmonary syndrome, low albumin levels, anemia, respiratory muscle weakness,
        and extreme hepatomegaly are still considered among the factors implicated in the
        pathogenesis of hypoxemia in cirrhosis .Pulmonary complications such as hepatopulmonary
        syndrome and pulmonary hypertension are observed frequently in these patients. The clinical
        picture characterized by hypoxemia in absence of primary heart and lung diseases in patients
        with liver failure is called hepatopulmonary syndrome. In hepatopulmonary syndrome, there is
        an increase in the alveolar-arterial oxygen gradient and a concomitant dilatation of the
        intrapulmonary vasculature during the inhalation of room air in addition to liver disease.
        Varying degrees of pulmonary findings including dyspnea, cyanosis, clubbing, and platypnea
        due to dilatations in the intrapulmonary vasculature (increase in dyspnea upon the shift from
        lying to standing position) and orthodeoxia (increase in hypoxia upon the shift from lying to
        standing position), and hypoxemia are seen in patients with HPS in cirrhotic and HCC
        patients.In general, PFT is employed to measure lung volumes, bronchial obstruction, gas
        exchange, lung compliance, and ventilatory capacity. Interstitial lung diseases (ILDs) are
        characterized by reduced lung volumes (restrictive ventilatory impairment), reduced (static)
        lung compliance, and reduced diffusing capacity. The pattern of lung function impairments
        does not allow a specific diagnosis to be made, but rather enables one to assess the presence
        or absence and the severity of lung involvement. Spirometry is a simple test to measure
        static lung volumes at rest-slow (inspiratory or expiratory) vital capacity (SVC), forced
        vital capacity (FVC)-and dynamic volumes-forced expiratory volume in 1 s (FEV1), flow-volume
        loops
  observational model: Case-Control
  time perspective: Prospective
  measure: pulmonary complications of liver cirrhosior or HCC
  time frame: from 1-9-2023 to 1-9-2024
  description: assess pulmonary functions impairement and complications due to liver cirrhosis or HCC using spirometer device parameters.
  arm group label: case
  description: cases are cirrhotic with hepatocellular carcinoma
  arm group label: control
  description: patients with cirrhosis
  intervention type: Device
  intervention name: spirometry
  description: pulmonary function tests using spirometry
  arm group label: case
  arm group label: control
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: youssef Mohammed mahmoud, Resident
  phone: 01062610036
  email: youssefmohamed@med.sohag.edu.eg
  last name: mahmoud saif Al-Islam, Professor
  facility: 
  contact: 
  country: Egypt
  citation: Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.
  PMID: 29307467
  citation: Fukui H, Saito H, Ueno Y, Uto H, Obara K, Sakaida I, Shibuya A, Seike M, Nagoshi S, Segawa M, Tsubouchi H, Moriwaki H, Kato A, Hashimoto E, Michitaka K, Murawaki T, Sugano K, Watanabe M, Shimosegawa T. Evidence-based clinical practice guidelines for liver cirrhosis 2015. J Gastroenterol. 2016 Jul;51(7):629-50. doi: 10.1007/s00535-016-1216-y. Epub 2016 May 31.
  PMID: 27246107
  citation: Lima B, Martinelli A, Franca AV. [Hepatopulmonary syndrome: pathogenesis, diagnosis and treatment]. Arq Gastroenterol. 2004 Oct-Dec;41(4):250-8. doi: 10.1590/s0004-28032004000400010. Epub 2005 Mar 29. Portuguese.
  PMID: 15806270
  citation: Przybylowski T, Krenke R, Fangrat A, Nasilowski J, Grabczak EM, Styczynski G, Pruszczyk P, Krawczyk M, Chazan R. Gas exchange abnormalities in patients listed for liver transplantation. J Physiol Pharmacol. 2006 Sep;57 Suppl 4:313-23.
  PMID: 17072060
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Youssef Mohamed Mahmoud
  investigator title: Resident of Tropical medicine and gastroenterology department, Sohag University Hospitals
  mesh term: Carcinoma, Hepatocellular
  mesh term: Liver Cirrhosis
  sharing ipd: Undecided