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临床试验/CTRI/2023/06/053505
CTRI/2023/06/053505招募中3 期

RIGHT LOBE VERSUS LEFT LOBE LIVER BIOPSY UNDER ENDOSCOPIC ULTRASOUND GUIDANCE: A PROSPECTIVE COMPARATIVE STUDY

Jayanta Samanta1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年6月15日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
28
试验地点
1
主要终点
Number of complete portal tracts (CPT)

研究概览

简要总结

Liver biopsy is the gold standard method for accurate assessment in the diagnosis and staging of liver diseases. A substantial number of liver diseases with diagnostic dilemmas after non-invasive tests are conclusively diagnosed by histopathology.  EUS guided liver biopsy (EUS-LB) is currently emerging as a cost effective, safe and well tolerated procedure and helps in more representative sampling. Various advancements have since been made in the technique of EUS-LB to maximize specimen quality. Studies have been published based on needle size, needle type, suction technique and number of needle actuation. Till date limited study exists as to whether one should perform left lobe or a right lobe liver biopsy. EUS-LB can be performed from either transgastric or a transduodenal station and multiple studies published till date have reported results from left lobe biopsy. Hence this study was planned comparing right versus left lobe EUS-guided liver biopsy in terms of adequacy of tissue sample and adverse event profile. It will also allow us to establish whether bilobar liver biopsy has any added advantage over either lobe (right/left) liver biopsy.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients requiring liver biopsy 2.Informed consent obtained from the patient 3.Patients >18 years old.

排除标准

  • 1.Unable to obtain informed consent from the patient 2.Medically unfit for sedation 3.Pregnant patient 4.Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging 5.Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5 6.Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure 7.Hemophilia 8.Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. biliary obstruction during EUS examination 9.Suspected or proven malignant liver disease.
  • 10.severe cardiovascular and pulmonary diseases.

结局指标

主要结局

Number of complete portal tracts (CPT)

时间窗: At procedure.

次要结局

  • 1.Post processing maximum (or aggregate) specimen length(2.Length of the longest specimen)
  • 5.Assessment of pain scores (subjective & objective)(6.Pain medication requirement: use of narcotics/analgesics in both arms, post-procedure)
  • 7. Rate of adverse events(Immediate post procedure, 24 hr, 1 week)

研究者

申办方类型
Other [self]

研究点 (1)

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