Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325436
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-16
Brief Title:
Objective Scores in Variceal Bleeding
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Accuracy of Simple Objective Scores in Prediction of Short-Term Outcome Among Cirrhotic Patients With Variceal Bleeding
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23
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 encephalopathy14 and some studies suggest that it may provide bettersimilar 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 1421 MELD 30 affords more accurate mortality prediction in general than MELD Na and addresses determinants of waitlist outcomes including the sex disparity 22
A MELD 30 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
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 encephalopathy14 and some studies suggest that it may provide bettersimilar 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 1421 MELD 30 affords more accurate mortality prediction in general than MELD Na and addresses determinants of waitlist outcomes including the sex disparity 22
A MELD 30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None