Clinical trial NCT06325436: Objective Scores in Variceal Bleeding
Official title: Accuracy of Simple Objective Scores in Prediction of Short-Term Outcome Among Cirrhotic Patients With Variceal Bleeding
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Variceal Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any cirrhotic patients present with variceal bleeding.

Brief summary: To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.

Detailed description: Acute variceal bleeding is the most common feature of decompensation in patients with cirrhosis and one of the life-threatening complications, causing significant morbidity and mortality in patients with cirrhosis 2,3.

Although much progress has been made in diagnosis and treatment the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days 4-5.

It is therefore critical to develop a prognostic method for patients with acute variceal bleeding to determine the risk of re-bleeding 6 and resistance to standard treatment (accounting for 20-30%) 7 and death to adopt more aggressive treatment measures.

Many existing scoring systems have been used to evaluate the prognosis of patients with variceal bleeding, but none of them are targeted: including the Child-Pugh score, Model for End-Stage Liver Disease (MELD), and MELD-Na, clinical Rockall score (CRS), AIMS65 score (AIMS65), and Glasgow-Blatchford score (GBS) 9-11 However, these scores have the limitation that some information is subjective, and they use several tests that are less specific for liver disease, meaning that the best method to stratify risk of re-bleeding and morality among cirrhotic patients is still not clear.

In recent years, some new scores have been introduced. One of these scoring systems is the serum albumin and total bilirubin (ALBI) score that was developed to assess outcome in patients with hepatocellular carcinoma (HCC) and primary biliary cholangitis.

ALBI grade is a simple score derived from an easily accessible without using those factors evaluated subjectively (such as ascites and encephalopathy)14 and some studies suggest that it may provide better/similar prognostic performance compared with other well established prognostic scores like CTP score, MELD score 15.

The platelet-albumin-bilirubin (PALBI) score16 was initially used for the assessment of patients with HCC undergoing resection or ablation and later has been used as a predictor of mortality in patients with cirrhosis related complications 17.

PALBI score on admission is a good prognostic indicator for patients with acute variceal bleeding and predicts early mortality and rebleeding. The PALBI score performed better in predicting short-term outcome and the incidence of rebleeding compared with the other 4 scoring systems for acute variceal bleeding 18 .

Another simple score, the international normalized ratio-albumin-bilirubin (INR-ALBL) score, to predict rebleeding in patients with esopho-gastric variceal bleeding following endoscopic therapy for liver cirrhosis19.

The INR-ALB grading system successfully assessed rebleeding, particularly early rebleeding, in cirrhotic patients with EGVB following endoscopic therapy. 20.

These ALBI -associated scores have received a lot of attention and are considered potential alternatives to CTP and MELD as prognostic indicators in patients with liver cirrhosis. These objective scores are considered better predictors of liver decompensated events, especially in stratifying risk for portal hypertension 14,21 MELD 3.0 affords more accurate mortality prediction in general than MELD Na and addresses determinants of waitlist outcomes including the sex disparity 22.

A MELD 3.0 less than 12 was associated with less than 5 % mortality and \>20 was associated with \>20% mortality 23.

Secondary to drawbacks of CTP (evaluated subjectively) and MELD (complexity in its calculation) for prognosis of patients with variceal bleeding, ALBI -associated scores (ALBI, PALBI and INR-ALBI) could be rapid, effective, and validated scores in prediction the outcome of such patients and to identify candidates for an early transjugular intrahepatic porto-systemic shunt procedure.

Eligibility criteria: Inclusion Criteria:

* Any cirrhotic patients above the age of 18 years old of both sexes, present with variceal bleeding.

Exclusion Criteria:

* Patients with other causes of upper gastrointestinal bleeding (UGIB).
* Patients who are receiving anticoagulant or antiplatelet therapy.
* Patients with HCC, other malignant tumors, and hematological disease at the time of recruitment or during follow up.
* Patients who underwent transjugular intrahepatic portosystemic shunt, splenectomy, or partial splenic embolization.
* Patients with liver cirrhosis and portal vein thrombosis.

Primary outcomes:
measure: assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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