肝疾患患者における経頸静脈肝生検の安全性と適切性: SAFE-TJLB 研究
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
National Capital Territory of Delhi
-
New Delhi、National Capital Territory of Delhi、インド、110070
- Institute of Liver & Biliary Sciences
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Liver Diseases of all etiologies
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
経頸静脈肝生検を受ける肝疾患患者
|
No intervention |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
長さ1.5cmを超える肝生検を受けた患者数
時間枠:0日目
|
0日目
|
|
有害事象
時間枠:7日目
|
7日目
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
処置時間(カテーテルの出入り)
時間枠:0日目
|
0日目
|
|
|
パス数
時間枠:0日目
|
0日目
|
|
|
故障率
時間枠:0日目
|
0日目
|
|
|
合併症 - 不整脈、血腫を有する患者の数
時間枠:0日目
|
0日目
|
|
|
蛍光灯照射時間
時間枠:0日目
|
0日目
|
|
|
保育時間
時間枠:1日目
|
1日目
|
|
|
VAS: pain (Abdomen and Neck, pre and post procedure)
時間枠:Day 0
|
VAS=10 is maximum pain |
Day 0
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。