Cirrhosis, LiverNCT05503836
Assessment of Severity of Liver Disease Before Surgery
An observational study of Cirrhosis, Liver, run by Assiut University.
Trial summary
Determine the ability of Child Pugh, MELD, and ALBI scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries. Evaluate the prognostic efficacy of ALBI score versus CTP and MELD scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- abdominal surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 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 75 years
- All sexes
- Adult, Older adult
Study population: All confirmed cases of cirrhosis aged ≥ 18 years of either sex, admitted to the Assiut university hospitals for abdominal surgeries (elective or emergency) .
Who may be able to join
- o All confirmed cases of cirrhosis aged ≥ 18 years of either sex, admitted to the Assiut university hospitals for abdominal surgeries (elective or emergency) were enrolled in the study.
- Cirrhosis is confirmed by the following diagnostic criteria :
- Clinical history and examination with special stress on symptoms and signs of chronic liver disease with or without evidence of hepatic decompensation e.g. the presence of ascites and with or without evidence of complications e.g. jaundice, bleeding varices, ascites, and lower limb edema.
- Laboratory findings in the form of raised bilirubin, impaired coagulation profile, and/or low serum albumin.
- Abdominal ultrasonography revealing liver cirrhosis (coarse echo pattern, attenuated hepatic veins, irregular outlines, hypertrophy of caudate lobe and/or shrunken liver, and presence of splenomegaly, ascites )
Who cannot join
- o Cirrhotic patients undergoing extra abdominal surgeries.
- Patients admitted for liver transplantation.
- Patients less than 18 years of age.
- Patients refused to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Different Scores for Prediction of Morbidity and Mortality in Cirrhotic Patients Undergoing Abdominal Surgeries
- Determine the ability of Child Pugh, MELD, and ALBI scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries.
- Evaluate the prognostic efficacy of ALBI score versus CTP and MELD scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries
Read the detailed description
Cirrhotic patients have a great risk for increased morbidity and mortality rather than the normal population after undergoing surgical procedures.(1) High mortality rates were reported among patients with liver cirrhosis as high as 67 % after surgical interventions. (2) This high surgical risk occurs is contributing to the pathophysiology of the diseased liver itself and to the presence of contributing factors, such as coagulopathy, poor nutritional status, adaptive immune dysfunction, cirrhotic cardiomyopathy, and renal and pulmonary dysfunction, which all predisposing to poor outcomes. Preoperative optimization after risk stratification and careful management are mandatory before surgery.(1) The challenge is to assess the surgical risks before deciding whether the procedure will be carried out safely or should be delayed until the patient underwent liver transplantation, or it should be avoided completely, and so early involvement of an experienced surgical and medical team is important.(1) The degree of hepatic dysfunction is one of the most risk factors for post-operative mortality and complication, other factors are considered as non-hepatic comorbidities, type of surgical procedures and the expertise of the managing team.(3) Various score systems are being used in clinical practice, for assessment of prognosis among cirrhotic patients such as the Child-Turcotte score, Model for End stage Liver Disease (MELD), . However, these scoring systems have several limitations in their prognostic implications. Although CTP scoring is easily applicable at bedside, the interpretation of ascites and encephalopathy is subjective in nature and equal point allocation of all variables make its results unstable.(4, 5) Also, the wide reference ranges for grading cirrhosis and its complications, such as ascites, bleeding, spontaneous bacterial peritonitis (SBP), and hepato-pulmonary syndrome, restricts the predictive accuracy of the MELD score. This raises a need for evaluating other potential biomarkers to strengthen prognostication and severity of cirrhosis (3).
Recently, the albumin-to-bilirubin (ALBI) score has emerged to evaluate severity of liver disease in hepatocellular carcinoma (HCC) (5) The ALBI is a new and simple score, easily calculated at bedside without having to use subjective determinants such as ascites and encephalopathy and because the ALB and TB levels are indicators of liver function, and can reflect the synthesis and metabolic function of the liver , so Its prognostic role in various liver diseases has recently been validated in several studies where it was found to be superior to CTP and MELD in assessing severity of liver disease.(4, 6, 7)
In general, ALBI grades 1, 2, and 3 correspond to Child-Pugh A, B, and C, respectively, and it was reported that the ALBI grade is more accurate in prediction of postoperative liver failure than the Child-Pugh grade. However, the Child-Pugh grade itself is a relatively rough grading system and was not intended for the prediction of liver failure after hepatectomy .(8)
- Conditions
- Cirrhosis, Liver
- Being tested
- abdominal surgeries
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal surgeriesProcedure or surgery
abdominal surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of deaths and number of cases with hepatic decompensation and compliication
As we will follow up the patient for 30 days after surgery
Measured: Between August 2022 and August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start15 Aug 2022 (estimated)
- Primary completion30 Aug 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 (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Khaled, Assiut University
- Investigators
- .Mohamed Omar, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503836
- Sponsor's protocol ID
- surgery in cirrhotic patients
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
Publications
Naqvi IH, Talib A, Mahmood K, Abidi R, Rizvi SNZ. The ability of the new ALBI scoring in predicting mortality, complications and prognostic comparison among cirrhotics. Prz Gastroenterol. 2019;14(4):250-257. doi: 10.5114/pg.2019.83872. Epub 2019 Mar 25.
PubMed 31988671
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Scores for Prediction of Morbidity and Mortality in Cirrhotic Patients Undergoing Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT05503836
- Acronym / sponsor ID
- surgery in cirrhotic patients
- Conditions
- Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 17 Aug 2022 (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.
- Determine the ability of Child Pugh, MELD, and ALBI scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries.
- Evaluate the prognostic efficacy of ALBI score versus CTP and MELD scores to predict mortality and morbidity in cirrhotic patients undergoing abdominal surgeries
Detailed description
Cirrhotic patients have a great risk for increased morbidity and mortality rather than the normal population after undergoing surgical procedures.(1) High mortality rates were reported among patients with liver cirrhosis as high as 67 % after surgical interventions. (2) This high surgical risk occurs is contributing to the pathophysiology of the diseased liver itself and to the presence of contributing factors, such as coagulopathy, poor nutritional status, adaptive immune dysfunction, cirrhotic cardiomyopathy, and renal and pulmonary dysfunction, which all predisposing to poor outcomes. Preoperative optimization after risk stratification and careful management are mandatory before surgery.(1) The challenge is to assess the surgical risks before deciding whether the procedure will be carried out safely or should be delayed until the patient underwent liver transplantation, or it should be avoided completely, and so early involvement of an experienced surgical and medical team is important.(1) The degree of hepatic dysfunction is one of the most risk factors for post-operative mortality and complication, other factors are considered as non-hepatic comorbidities, type of surgical procedures and the expertise of the managing team.(3) Various score systems are being used in clinical practice, for assessment of prognosis among cirrhotic patients such as the Child-Turcotte score, Model for End stage Liver Disease (MELD), . However, these scoring systems have several limitations in their prognostic implications. Although CTP scoring is easily applicable at bedside, the interpretation of ascites and encephalopathy is subjective in nature and equal point allocation of all variables make its results unstable.(4, 5) Also, the wide reference ranges for grading cirrhosis and its complications, such as ascites, bleeding, spontaneous bacterial peritonitis (SBP), and hepato-pulmonary syndrome, restricts the predictive accuracy of the MELD score. This raises a need for evaluating other potential biomarkers to strengthen prognostication and severity of cirrhosis (3).
Recently, the albumin-to-bilirubin (ALBI) score has emerged to evaluate severity of liver disease in hepatocellular carcinoma (HCC) (5) The ALBI is a new and simple score, easily calculated at bedside without having to use subjective determinants such as ascites and encephalopathy and because the ALB and TB levels are indicators of liver function, and can reflect the synthesis and metabolic function of the liver , so Its prognostic role in various liver diseases has recently been validated in several studies where it was found to be superior to CTP and MELD in assessing severity of liver disease.(4, 6, 7)
In general, ALBI grades 1, 2, and 3 correspond to Child-Pugh A, B, and C, respectively, and it was reported that the ALBI grade is more accurate in prediction of postoperative liver failure than the Child-Pugh grade. However, the Child-Pugh grade itself is a relatively rough grading system and was not intended for the prediction of liver failure after hepatectomy .(8)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All confirmed cases of cirrhosis aged ≥ 18 years of either sex, admitted to the Assiut university hospitals for abdominal surgeries (elective or emergency) .
Key inclusion criteria (5 listed)
- o All confirmed cases of cirrhosis aged ≥ 18 years of either sex, admitted to the Assiut university hospitals for abdominal surgeries (elective or emergency) were enrolled in the study.
Key exclusion criteria (4 listed)
- o Cirrhotic patients undergoing extra abdominal surgeries.
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 |
|---|---|---|
| abdominal surgeriesabdominal surgeries | Procedure or surgery | – |
Primary outcome
frequency of deaths and number of cases with hepatic decompensation and compliication
Time frame: Between August 2022 and August 2024
As we will follow up the patient for 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 31988671Naqvi IH, Talib A, Mahmood K, Abidi R, Rizvi SNZ. The ability of the new ALBI scoring in predicting mortality, complications and prognostic comparison among cirrhotics. Prz Gastroenterol. 2019;14(4):250-257. doi: 10.5114/pg.2019.83872. Epub 2019 Mar 25.
Related trials for Cirrhosis, Liver
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
.Mohamed Omar, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver, run by Assiut University.
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 5 inclusion and 4 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Tasneem Khaled, Ass. lecturer (01098292141, tasneemkhaled23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of deaths and number of cases with hepatic decompensation and compliication (time frame: Between August 2022 and August 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 NCT05503836, which also lists 1 linked publication.
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 17 Aug 2022.