- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06469489
Säkerhet och tillräcklighet för transjugulär leverbiopsi hos patienter med leversjukdom: SAFE-TJLB-studie
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- Adequacy of trans-jugular liver biopsy
- Safety of trans-jugular liver biopsy
Secondary objective:
- Indications of liver biopsy
- Procedural time (in and out of catheter)
- Number of passes
- Failure rate
- Day care time
- VAS: pain (Abdomen and Neck, pre and post procedure)
- Complications- arrythmia, hematoma
- 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). The study comprises two components: a retrospective component covering the period from January 2020 to May 2024, and a prospective component from June 2024 to May 2025.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Indien, 110070
- Institute of Liver & Biliary Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Liver Diseases of all etiologies
Beskrivning
Inclusion Criteria:
- 18-65 years age.
- Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Patienter med leversjukdom som genomgår transjugulär leverbiopsi
|
No intervention |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Antal patienter med leverbiopsi som tagits över 1,5 cm långa
Tidsram: Dag 0
|
Dag 0
|
|
Biverkning
Tidsram: Dag 7
|
Dag 7
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procedurtid (in och ut ur katetern)
Tidsram: Dag 0
|
Dag 0
|
|
|
Antal pass
Tidsram: Dag 0
|
Dag 0
|
|
|
Misslyckandefrekvens
Tidsram: Dag 0
|
Dag 0
|
|
|
Antal patienter med komplikationer- arytmi, hematom
Tidsram: Dag 0
|
Dag 0
|
|
|
Tid för fluorexponering
Tidsram: Dag 0
|
Dag 0
|
|
|
Dagvårdstid
Tidsram: Dag 1
|
Dag 1
|
|
|
VAS: pain (Abdomen and Neck, pre and post procedure)
Tidsram: Day 0
|
VAS=10 is maximum pain |
Day 0
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ILBS-SAFE-TJLB
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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