Pulmonary Complications of Liver Cirrhosis and HCCNCT05963776
Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma
An observational study of Pulmonary Complications of Liver Cirrhosis and HCC, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pulmonary Complications of Liver Cirrhosis and HCC
- What is being tested?
- spirometry
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with liver cirrhosis with and without HCC depending on clinical evidence of stigmata of liver disease (e.g. jaundice, ascites, palmar erythema, spider navi, etc), laboratory data and ultra-sonographic features.
Who may be able to join
- Adult patients diagnosed with liver cirrhosis with and without HCC depending on clinical evidence of stigmata of liver disease (e.g. jaundice, ascites, palmar erythema, spider navi, etc), laboratory data and ultra-sonographic features.
Who cannot join
- Patients with primary pulmonary pathology.
- Coexisting intrinsic heart disease.
Trial locations and contacts
1 site in 1 country.
mahmoud saif Al-Islam, Professor contact
About this study
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.
Read the detailed description
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
- Being tested
- spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDevice
pulmonary function tests using spirometry
| Study group | Role | What they receive |
|---|---|---|
| case | cases are cirrhotic with hepatocellular carcinoma Receives: Device: spirometry | |
| control | patients with cirrhosis Receives: Device: spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary complications of liver cirrhosior or HCC
assess pulmonary functions impairement and complications due to liver cirrhosis or HCC using spirometer device parameters.
Measured: from 1-9-2023 to 1-9-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Complications of Liver Cirrhosis and HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Mohamed Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963776
- Sponsor's protocol ID
- Soh-Med-23-05-02MS
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29307467Fukui 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.
PubMed 27246107Lima 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.
PubMed 15806270Przybylowski 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.
PubMed 17072060
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05963776
- Acronym / sponsor ID
- Soh-Med-23-05-02MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Device: spirometrycases are cirrhotic with hepatocellular carcinoma |
| control | – | Device: spirometrypatients with cirrhosis |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with liver cirrhosis with and without HCC depending on clinical evidence of stigmata of liver disease (e.g. jaundice, ascites, palmar erythema, spider navi, etc), laboratory data and ultra-sonographic features.
Key inclusion criteria (1 listed)
- Adult patients diagnosed with liver cirrhosis with and without HCC depending on clinical evidence of stigmata of liver disease (e.g. jaundice, ascites, palmar erythema, spider navi, etc), laboratory data and ultra-sonographic features.
Key exclusion criteria (2 listed)
- Patients with primary pulmonary pathology.
- Coexisting intrinsic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometrypulmonary function tests using spirometry | Device | case, control |
Primary outcome
pulmonary complications of liver cirrhosior or HCC
Time frame: from 1-9-2023 to 1-9-2024
assess pulmonary functions impairement and complications due to liver cirrhosis or HCC using spirometer device parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 29307467Forner 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.
- Background: PubMed 27246107Fukui 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.
- Background: PubMed 15806270Lima 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.
- Background: PubMed 17072060Przybylowski 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mahmoud saif Al-Islam, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Complications of Liver Cirrhosis and HCC, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact youssef Mohammed mahmoud, Resident (01062610036, youssefmohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary complications of liver cirrhosior or HCC (time frame: from 1-9-2023 to 1-9-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963776, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.