Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469489
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-01-03
Brief Title:
Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease SAFE-TJLB Study
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease SAFE-TJLB Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders Liver biopsy provides information regarding diagnosis disease progression and response to therapy in patients with chronic liver diseases Trans-jugular liver biopsy TJLB consists of obtaining liver tissue through a rigid cannula introduced into one of the hepatic veins typically using jugular venous access This approach reduces the risk of hemorrhage after biopsy because the bleeding resulting from the biopsy needle will drain into the hepatic veins In the past the specimens obtained by a transjugular approach were considered suboptimal compared with the samples obtained with percutaneous needles because they were smaller and more fragmented TJLB was initially indicated for patients who had a contraindication to percutaneous biopsy such as those with a coagulopathy or congenital clotting disorders ascites acute liver failure large amount of adipose tissue and patients after liver transplantation The clinical role of TJLB has expanded due to the possibility of performing hemodynamic evaluation of the hepatic and portal venous systems which provides useful information and may guide therapy in patients with portal hypertension
Lacuna in literature
There is no prospective study in India evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease
Lacuna in literature
There is no prospective study in India evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease
Detailed Description:
Hypothesis
Trans-jugular liver biopsy is safe gives adequate sample for pathological examination in patients with liver disease
Aim of study
To evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease
Primary objective
1 Adequacy of trans-jugular liver biopsy
2 Safety of trans-jugular liver biopsy
Secondary objective
1 Indications of liver biopsy
2 Procedural time in and out of catheter
3 Number of passes
4 Failure rate
5 Day care time
6 VAS pain Abdomen and Neck pre and post procedure
7 Complications- arrythmia hematoma
8 Time of Fluro exposure
Patients and methods Study Design A prospective observational cohort study will be conducted in patients with suspected or known liver disease between November 2023 to May 2024 at the Institute of Liver and Biliary Sciences ILBS New Delhi
Clinical protocol An informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication The following demographic data was recorded at inclusion Age gender co-morbidities type and etiology of liver disease Laboratory parameters include complete blood count liver function tests kidney function tests INR Severity of liver disease MELD score CTP score AARC score
Trans-jugular liver biopsy is safe gives adequate sample for pathological examination in patients with liver disease
Aim of study
To evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease
Primary objective
1 Adequacy of trans-jugular liver biopsy
2 Safety of trans-jugular liver biopsy
Secondary objective
1 Indications of liver biopsy
2 Procedural time in and out of catheter
3 Number of passes
4 Failure rate
5 Day care time
6 VAS pain Abdomen and Neck pre and post procedure
7 Complications- arrythmia hematoma
8 Time of Fluro exposure
Patients and methods Study Design A prospective observational cohort study will be conducted in patients with suspected or known liver disease between November 2023 to May 2024 at the Institute of Liver and Biliary Sciences ILBS New Delhi
Clinical protocol An informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication The following demographic data was recorded at inclusion Age gender co-morbidities type and etiology of liver disease Laboratory parameters include complete blood count liver function tests kidney function tests INR Severity of liver disease MELD score CTP score AARC score
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