Pulmonary Function Tests Study in Cirrhotic Patients With and Without Hepatocellular Carcinoma

NCT05963776 | Unknown

• 1 other identifier: Soh-Med-23-05-02MS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Complications of Liver Cirrhosis and HCC

Outcome Measures

Primary Outcomes (1)

• pulmonary complications of liver cirrhosior or HCC

  assess pulmonary functions impairement and complications due to liver cirrhosis or HCC using spirometer device parameters.

  from 1-9-2023 to 1-9-2024

Study Arms (2)

case

cases are cirrhotic with hepatocellular carcinoma

Device: spirometry

control

patients with cirrhosis

Device: spirometry

Interventions

spirometry DEVICE

pulmonary function tests using spirometry

case; control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with primary pulmonary pathology.
• Coexisting intrinsic heart disease.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Spirometry

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

youssef Mohammed mahmoud, Resident

CONTACT

01062610036; youssefmohamed@med.sohag.edu.eg

mahmoud saif Al-Islam, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Tropical medicine and gastroenterology department, Sohag University Hospitals

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

EG (1)