Trial Title:
Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma
NCT ID:
NCT05963776
Condition:
Pulmonary Complications of Liver Cirrhosis and HCC
Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Cirrhosis
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
spirometry
Description:
pulmonary function tests using spirometry
Arm group label:
case
Arm group label:
control
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. 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
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with primary pulmonary pathology.
- Coexisting intrinsic heart disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sohag University hospitals
Address:
City:
Sohag
Country:
Egypt
Contact:
Last name:
Magdy M Amin, Professor
Start date:
September 1, 2023
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Sohag University
Agency class:
Other
Source:
Sohag University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963776
