Bloody or Well Done. How Would You Like Your Liver Biopsy, Sir? Post Liver bIopsy abdoMinal PaIn as Predictive Factor for Liver bleeDing (LIMPID)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Post procedure pain at 2 hours after procedure
研究概览
简要总结
This is a randomized comparative trial between percutaneous liver biopsy and EUS FNB guided liver biopsy in patients with parenchymal liver disease.
Studies so far have been shown that EUS FNB guided liver biopsy is non inferior to percutaneous liver biopsy in terms of efficacy, provided several conditions are met (type of needle, wet suction, actuations).
În terms of safety, it may be that EUS FNB have an advantage, as needle diameter is slightly smaller, needle is inserted under better visualisation especially in patients with large subcutaneous fat tissue and the possibility of examining the needle tract and plugging it with needle content if needed ("the blood patch technique").
However, although severe, the incidence of liver bleeding is low, so a comparative trial with the hypothesis that EUS FNB has fewer liver bleedings than percutaneous techniques would have a very large sample size.
A recent study found out that abdominal pain at 2 hours after procedure is predictive for liver bleeding.
So we have design a randomized prospective trial assuming that EUS FNB guided liver biopsy has significantly less abdominal pain at 2 hours after procedure when compared to percutaneous route, using abdominal pain at 2 hours as a surrogate marker for risk of liver bleeding.
详细描述
Why liver biopsy? Parenchymal liver diseases need sometimes diagnostic or staging assessment liver biopsy (eg. autoimmune hepatitis, primary biliary cholangitis, metabolic dysfunction associated fatty liver disease - MAFLD). Also, some focal liver lesions may need a diagnostic liver biopsy (eg. primitive liver tumors, liver metastases).
This can be performed percutaneously, trans-jugular and more recently trans-gastric or trans-duodenal under endoscopic ultrasound (EUS) guidance. The trans-jugular route was proposed for patients with coagulation disorders, as there is virtually no risk of bleeding, as the procedure is done within the supra-hepatic veins.
Currently, evidence exist that optimal results for EUS guided fine needle biopsy (FNB) are obtained by using a 19 Gauge Franseen FNB needle, by the heparin primed "wet suction" technique, with one or two passes (in both liver lobes), with at least 3 needle actuations [1,2,3,4]. Ensuring these conditions, the outcomes are non-inferior to percutaneous liver biopsy (length of the specimen, number of portal tracts, diagnostic accuracy).
So why choose EUS guided liver FNB? Two percutaneous liver biopsy adverse reactions are probably responsible for one's apprehension towards it - post procedure abdominal pain and the risk of liver bleeding. A recent meta-analysis [5] has found an incidence of mild abdominal pain at 12.9% and moderate-severe abdominal pain at 0.34%. The percentages for liver bleeding were 0.48% for major bleeding, 0.11% for major hematoma, 0.06% for hemoperitoneum and 0.01% for haemobilia (0.66% in total).
Bisonnette et al [6] have tried to find predictive factors for liver bleeding after percutaneous or trans-jugular liver biopsy. The only predictive factor was pain at 2h liver biopsy. This was more frequent following percutaneous than trans-jugular liver biopsy (33% vs. 15%; p < .001). Out of all patients with pain 2 h after liver biopsy, 15% had a liver biopsy-related bleeding, while out of those without pain 2 h after liver biopsy, 4% had a liver biopsy-related bleeding (p = .002). Pain 2 h after liver biopsy had a 55% (95% CI 0.35-0.73) sensitivity, 75% (95% CI 0.70-0.80) specificity, and 96% (95% CI 0.93-0.97) negative predictive value for liver biopsy -related bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diffuse parenchymal liver disease with indication for liver biopsy for diagnostic and/or staging purposes,
- •Eligibility for deep sedation with propofol
- •Age above 18 years old
- •Informed consent
排除标准
- •Coagulation disorders which cannot be corrected
- •Anticoagulant and/or antiagregant medication which cannot be stopped temporarily.
- •Contraindications for liver biopsy, to local lidocaine anesthesia and to deep propofol sedation
- •Absence of written informed consent
结局指标
主要结局
Post procedure pain at 2 hours after procedure
时间窗: 2 hours
Post procedure pain at 2 hours measured by Visual Analogue Scale (0 - 10)
次要结局
- Longest intact specimen(2 hours)
- Total specimen complete portal tracts (CPT)(28 days)
- Proportion of specimens with > 11 CPT(28 days)
- Post procedure pain at 24 hours after procedure(24 hours)
- Proportion of post procedure liver bleeding(7 days)
- Proportion of specimens > 20mm in aggregate length(2 hours)
- Aggregate specimen length(2 hours)
- Total number of specimens(2 hours)
- Proportion of specimen with conclusive pathological diagnosis(28 days)
研究者
Mihai Ciocirlan
Associate Professor of Gastroenterology
Carol Davila University of Medicine and Pharmacy