跳至主要内容
临床试验/CTRI/2025/02/080550
CTRI/2025/02/080550尚未招募2/3 期

To compare the diagnostic performance of different suction techniques during EUS - FNB for pancreatico-biliary lesions

AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年2月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
AIIMS Jodhpur
入组人数
96
试验地点
1
主要终点
Accuracy in diagnosing the lesions, compared with final diagnosis. Final diagnosis confirmed by three methods: the results of EUS-FNB, surgical pathology, if available, and clinical follow-up for at least 3 months

研究概览

简要总结

EUS FNB is now being considered the optimal technique for sampling of pancreaticobiliary lesions due to its high accuracy and less adverse complication rates. Currently, to the best of our knowledge, there is no data in India regarding the optimal sampling technique. This is a prospective, randomized controlled trail, with three arms, comparing the diagnostic efficacy of EUS FNB techniques – standard no suction vs stylet slow pull vs wet suction for pancreaticobilary lesion. We aim to include all patients more than 18 years presenting to us with indication of for EUS FNB for pancreaticobilary lesions and giving informed consent, excluding age morethan18, bleeding diathesis and pregnant women. We shall compare the three techniques by taking a biopsy consecutively with each sampling technique, and send each separately labelled sample to the pathologist, who is blinded to the technique of sampling and will report each sample individually and the results will be analysed according to the accuracy provided by the sampling technique and the final diagnosis, along with the tissue integrity and blood contamination. Further treatment will be as per treating physician. Expected outcome will be to compare the non inferiority of wet suction and slow stylet pull technique with the standard no suction technique.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age more than 18 years
  • patients with pancreatic, peripancreatic and pancreaticobiliary solid lesions which requires EUS- FNB for diagnosis
  • Informed consent is obtained.

排除标准

  • Age less than 18 years
  • Active gastrointestinal bleeding Bleeding tendency (platelet less than 50,000/mm3 and/or PT INR more than 1.5)
  • Pregnant patient
  • Unable to understand and/or read the informed consent.

结局指标

主要结局

Accuracy in diagnosing the lesions, compared with final diagnosis. Final diagnosis confirmed by three methods: the results of EUS-FNB, surgical pathology, if available, and clinical follow-up for at least 3 months

时间窗: At 3 months

次要结局

  • 1.Sensitivity of each technique(2.Specificity of each technique)

研究者

发起方
AIIMS Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ashish Agarwal

AIIMS Jodhpur

研究点 (1)

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