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Status unknownNCT05503836Updated Aug 17, 2022

Assessment of Severity of Liver Disease Before Surgery

An observational study in Cirrhosis, Liver, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
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Study 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 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)

02

Conditions studied

  • Cirrhosis, Liver

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03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 100 is below the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

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) .

Inclusion criteria

  • 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 :

      1. 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.
      2. Laboratory findings in the form of raised bilirubin, impaired coagulation profile, and/or low serum albumin.
      3. 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 )

Exclusion criteria

Exclusion Criteria:

  • o Cirrhotic patients undergoing extra abdominal surgeries.

    • Patients admitted for liver transplantation.
    • Patients less than 18 years of age.
    • Patients refused to participate.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Procedureabdominal surgeries

    abdominal surgeries

06

What researchers measure

Primary outcomes

  1. frequency of deaths and number of cases with hepatic decompensation and compliication

    As we will follow up the patient for 30 days after surgery

    Time frame: Between August 2022 and August 2024

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Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05503836
Lead sponsor
Assiut University
Responsible party
Tasneem Khaled (Assistant lecturer, Assiut University) — Principal investigator
First posted
Aug 17, 2022
Start date
Aug 15, 2022 (estimated)
Primary completion
Aug 30, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Aug 17, 2022

Study contacts

Tasneem Khaled, Ass. lecturer
Contact
tasneemkhaled23@gmail.com
01098292141
.Mohamed Omar, Professor
study director · Assiut University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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