跳至主要内容
临床试验/NCT05587933
NCT05587933尚未招募不适用

Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?

Assiut University0 个研究点目标入组 20 人开始时间: 2022年10月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria

研究概览

简要总结

In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.

详细描述

The flow of bile through the biliary system is a complex process that depends on the hormonal environment, digestive phase, and functional response of the gallbladder and sphincter of Oddi to all of these factors. Biliary dyskinesia is a disorder of some component of biliary part of the digestive system in which bile cannot physically flow in the proper direction through the tubular biliary tract which causes biliary colic as defined by Rome IV criteria.

Functional causes of biliary pain, also referred to as biliary dyskinesia, are biliary hypokinesia , biliary hyperkinesia and sphincter of Oddi dysfunction (SOD). The exact pathology of functional biliary colic is still unknown. Reviewing Literature status, There is still some debate about the best method to establish the diagnosis gallbladder dyskinesia and hyperkinesia and whether or not ejection fraction is an accurate predictor of outcome. Which led to difficult.

Biliary dyskinesia is identified through gallbladder ejection fraction (GBEF), which is calculated as the flow of radioactive tracer that is ejected from the gallbladder. A GBEF of <35% is considered dyskinesia and a GBEF of <35% is considered hyperkinesia. Patients considered for CCK-HIDA (cholecystokinin hepatobiliary iminodiacetic acid) are those presenting with functional biliary pain based on the Rome IV criteria. Those who present with atypical pain may not need as HIDA (hepatobiliary iminodiacetic acid) as the presentation may be from other pathology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
12 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 14 years of age
  • food-related abdominal pain
  • normal gallbladder ultrasound (US)
  • GB EF 80% and greater or 35% and less on HIDA scan with CCK injection

排除标准

  • Patients younger than 14 years old
  • Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (> 4 mm), pericholecystic fluid, sludge, or polyps
  • Normal GB EF

研究组 & 干预措施

operative

Experimental

干预措施: cholecystectomy (Procedure)

operative

Experimental

干预措施: Antispasmodic (Drug)

结局指标

主要结局

Rate of quality of life improvment after cholecystectomy according to ROME IV criteria

时间窗: 6 months

abdominal pain, nausea and vomiting

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Yassien Abd-Elkariem

General surgery resident

Assiut University

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