Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335186
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-20
Brief Title:
Predictive and Prognostic Significance of AgeBlood TestsComorbiditiesABC ScoreCologne WatchC-watchScore and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Predictive and Prognostic Significance of AgeBlood TestsComorbiditiesABC ScoreCologne WatchC-watchScore and Rockall Score for Risk of Variceal Re-bleeding Among Cirrhotic Patients
Status:
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:
Introduction
Portal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis The incidence of portal hypertension is approximately 20 to 98 in patients with cirrhosis Wu et al 2022 It is the major driver in the transition from the compensated to the decompensated stage of cirrhosis defined by the presence of clinical complications including ascites spontaneous bacterial peritonitis hepatorenal syndrome and hepatic encephalopathy Berzigotti 2017
Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up Furthermore variceal bleeding is associated with high risk of rebleeding and mortality Tantai et al 2019
Patients with cirrhosis although much progress has been made in diagnosis and treatment using vasoactive drugs preventive antibiotics early endoscopy and interventional radiology the 6-week mortality rate remains high ranging from 10 to 20 mainly due to failure to control bleeding in the first days Therefore the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment accounting for 20-30 and mortality rate in order to be able to adopt more aggressive treatment measures The prognosis is very important but also difficult not only because of the bleeding status but also depending on the severity of the underlying cirrhosis Huy et al 2023
Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding UGIB setting Age comorbidities presence of shock endoscopic diagnosis haemoglobin values at the time of bleeding stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death Monteiro S et al 2016
Many risk assessment score systems including pre-endoscopy and post-endoscopy evaluations have been developed to predict outcomes such as the need for hospital-based intervention endoscopic therapy and admission to an intensive care unit ICU rebleeding and mortality Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients allowing more efficient use of resources Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit Li et al 2022
In 1993 the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age score 0-2 presence of shock 0-2 co-morbidities score 0-3 and post endoscopic diagnosis score 0-2 with stigmata of recent hemorrhages score 0-2 Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 Dewan et al 2018
In 2020 Laursen SB and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score This scoring system is based on three criteria age blood test results and comorbidities The score ranges from 0 to 18 points categorizing the risk into low 3 points moderate 4-7 points and high 8 points levels The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1 7 and 25 respectively Ky et al 2023
The new Cologne Watch C-Watch score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only c-reactive protein white blood cell count alanine-aminotransferase thrombocytes creatinine and hemoglobin with a minimum point value of 0 and a maximum point value of 8 Within the validation set it predicted a composite endpoint consisting of recurrent bleeding need for intervention interventional radiology surgery or death within 30 days with an area under the receiver-operating characteristics curve AUROC of 0 About 387 of patients were within the high-risk group ie 2 points reached the composite endpoint whereas no patient classified as low risk 1 point Allo et al 2022
Portal hypertension is a common complication of liver cirrhosis and is often underestimated in clinical diagnosis The incidence of portal hypertension is approximately 20 to 98 in patients with cirrhosis Wu et al 2022 It is the major driver in the transition from the compensated to the decompensated stage of cirrhosis defined by the presence of clinical complications including ascites spontaneous bacterial peritonitis hepatorenal syndrome and hepatic encephalopathy Berzigotti 2017
Acute variceal bleeding is one of the most lifethreatening complications of liver cirrhosis Twenty two percent to sixty one percent of cirrhotic patients receiving primary prophylaxis will develop first variceal bleeding during the first two years of follow up Furthermore variceal bleeding is associated with high risk of rebleeding and mortality Tantai et al 2019
Patients with cirrhosis although much progress has been made in diagnosis and treatment using vasoactive drugs preventive antibiotics early endoscopy and interventional radiology the 6-week mortality rate remains high ranging from 10 to 20 mainly due to failure to control bleeding in the first days Therefore the prognostic method of patients with acute variceal bleeding is to determine the risk of rebleeding and resistance to standard treatment accounting for 20-30 and mortality rate in order to be able to adopt more aggressive treatment measures The prognosis is very important but also difficult not only because of the bleeding status but also depending on the severity of the underlying cirrhosis Huy et al 2023
Many risk factors are known to influence the outcome in Upper Gastrointestinal Bleeding UGIB setting Age comorbidities presence of shock endoscopic diagnosis haemoglobin values at the time of bleeding stigmata of recent haemorhage and need for blood transfusion have all been described as significant risk factors for rebleeding and death Monteiro S et al 2016
Many risk assessment score systems including pre-endoscopy and post-endoscopy evaluations have been developed to predict outcomes such as the need for hospital-based intervention endoscopic therapy and admission to an intensive care unit ICU rebleeding and mortality Some studies showed that these scoring systems distinguish low-risk patients who can potentially be managed as outpatients allowing more efficient use of resources Other studies suggested that these score systems distinguish higher-risk patients who might require emergency endoscopy or management in an intensive care unit Li et al 2022
In 1993 the Rockall Scoring system was introduced to predict the mortality after UGIB and was validated for its use to identify the patients at high risk for re-bleed and mortality Complete Rockall scoring system is based on an initial clinical score at the time of admission which consist of age score 0-2 presence of shock 0-2 co-morbidities score 0-3 and post endoscopic diagnosis score 0-2 with stigmata of recent hemorrhages score 0-2 Both clinical and post endoscopic scores added together gives a complete Rockall score with maximum score being 11 Dewan et al 2018
In 2020 Laursen SB and colleagues conducted a multicenter international study and developed a new prognostic scoring system for UGIB called the ABC score This scoring system is based on three criteria age blood test results and comorbidities The score ranges from 0 to 18 points categorizing the risk into low 3 points moderate 4-7 points and high 8 points levels The 30-day mortality rates for high-risk UGIB patients in these three risk groups were 1 7 and 25 respectively Ky et al 2023
The new Cologne Watch C-Watch score was designed as a pre-endoscopic score for acute variceal and non-variceal UGIB and incorporates laboratory values only c-reactive protein white blood cell count alanine-aminotransferase thrombocytes creatinine and hemoglobin with a minimum point value of 0 and a maximum point value of 8 Within the validation set it predicted a composite endpoint consisting of recurrent bleeding need for intervention interventional radiology surgery or death within 30 days with an area under the receiver-operating characteristics curve AUROC of 0 About 387 of patients were within the high-risk group ie 2 points reached the composite endpoint whereas no patient classified as low risk 1 point Allo et al 2022
Detailed Description:
Patients and methods
-Place of the study
Tropical Medicine and Gastroenterology Department of Sohag University Hospital
-Type of the study
Prospective cohort study
-Study period
Duration of study will be one year after protocol acceptance
-Patients
This study will include 100 cirrhotic Patients presenting with upper gastrointestinal variceal bleeding
-Inclusion criteria
Patients who met the following inclusion criteria were enrolled
1-History of chronic liver disease 2-Impaired liver function 3-Portal hypertension syndrome indicated by esophageal varices andor variceal dilation
4-Diagnostic imaging confirming liver cirrhosis on ultrasound who admitted to the hospital with symptoms of hematemesis andor melena underwent clinical and laboratory examinations and an upper gastrointestinal endoscopy and were diagnosed with UGIB due to ruptured esophageal ESOVs andor gastric varices GASVs
Exclusion criteria
1 UGIB caused by other cases such as Mallory-Weiss syndrome and esophageal or gastrointestinal ulcers
2 UGIB due to ruptured veins in conditions other than increased portal pressure like portal hypertension syndrome unrelated to cirrhosis
3 Patients with portal vein thrombosis
4 Patients used anticoagulant
Methods of the study
All participants will be subjected to
Complete history taking
Clinical examination
1 Vital signs pulse 60-100 blood pressure 9060-12080 and temperature 365-373
2 Complete general and local examination
Laboratory investigation
1 Complete blood count Hemoglobin Hb white blood cells WBC and platelet
2 Liver function test as alanine transaminase ALT aspartate transaminase AST Albumin total bilirubin Prothrombin time PT Prothrombin concentration PC International normalized ratio INR and child pugh score
3 Serum creatinineurea and C-reactive protein CRP
4 Ascitic fluid study for patients with ascites
Assessment of risk and predicting outcomes by
1 ABC score
2 C-watch score
3 Rockall score
Radiological investigation
Abdominal ultrasound with comment on
Liver size echopattern surface and focal lesion
Portal vein diameter patency and presence of collaterals
Spleen size echopattern and splenic vein diameter
Presence of ascites or not
Intervention
Upper endoscopy with comment on
Size of varices extension of varices and stigmata of recent bleeding
-Place of the study
Tropical Medicine and Gastroenterology Department of Sohag University Hospital
-Type of the study
Prospective cohort study
-Study period
Duration of study will be one year after protocol acceptance
-Patients
This study will include 100 cirrhotic Patients presenting with upper gastrointestinal variceal bleeding
-Inclusion criteria
Patients who met the following inclusion criteria were enrolled
1-History of chronic liver disease 2-Impaired liver function 3-Portal hypertension syndrome indicated by esophageal varices andor variceal dilation
4-Diagnostic imaging confirming liver cirrhosis on ultrasound who admitted to the hospital with symptoms of hematemesis andor melena underwent clinical and laboratory examinations and an upper gastrointestinal endoscopy and were diagnosed with UGIB due to ruptured esophageal ESOVs andor gastric varices GASVs
Exclusion criteria
1 UGIB caused by other cases such as Mallory-Weiss syndrome and esophageal or gastrointestinal ulcers
2 UGIB due to ruptured veins in conditions other than increased portal pressure like portal hypertension syndrome unrelated to cirrhosis
3 Patients with portal vein thrombosis
4 Patients used anticoagulant
Methods of the study
All participants will be subjected to
Complete history taking
Clinical examination
1 Vital signs pulse 60-100 blood pressure 9060-12080 and temperature 365-373
2 Complete general and local examination
Laboratory investigation
1 Complete blood count Hemoglobin Hb white blood cells WBC and platelet
2 Liver function test as alanine transaminase ALT aspartate transaminase AST Albumin total bilirubin Prothrombin time PT Prothrombin concentration PC International normalized ratio INR and child pugh score
3 Serum creatinineurea and C-reactive protein CRP
4 Ascitic fluid study for patients with ascites
Assessment of risk and predicting outcomes by
1 ABC score
2 C-watch score
3 Rockall score
Radiological investigation
Abdominal ultrasound with comment on
Liver size echopattern surface and focal lesion
Portal vein diameter patency and presence of collaterals
Spleen size echopattern and splenic vein diameter
Presence of ascites or not
Intervention
Upper endoscopy with comment on
Size of varices extension of varices and stigmata of recent bleeding
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