Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT05963776 |
Recruitment Status :
Not yet recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Pulmonary Complications of Liver Cirrhosis and HCC | Device: spirometry |
Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | September 1, 2024 |
Estimated Study Completion Date : | September 1, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
case
cases are cirrhotic with hepatocellular carcinoma
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Device: spirometry
pulmonary function tests using spirometry |
control
patients with cirrhosis
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Device: spirometry
pulmonary function tests using spirometry |
- 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.
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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05963776
Contact: youssef Mohammed mahmoud, Resident | 01062610036 | youssefmohamed@med.sohag.edu.eg | |
Contact: mahmoud saif Al-Islam, Professor |
Egypt | |
Sohag University hospitals | |
Sohag, Egypt | |
Contact: Magdy M Amin, Professor |
Responsible Party: | Youssef Mohamed Mahmoud, Resident of Tropical medicine and gastroenterology department, Sohag University Hospitals, Sohag University |
ClinicalTrials.gov Identifier: | NCT05963776 |
Other Study ID Numbers: |
Soh-Med-23-05-02MS |
First Posted: | July 27, 2023 Key Record Dates |
Last Update Posted: | July 27, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Hepatocellular Liver Cirrhosis Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Fibrosis Pathologic Processes |