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临床试验/NCT02748525
NCT02748525已完成4 期

Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年5月3日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Gallbladder Ejection Fraction

研究概览

简要总结

This study aims to combine the use of IV CCK administration followed by oral milk during a HIDA scan to further stimulate the gallbladder contractility and decrease the number of false abnormal HIDA scans and unnecessary cholecystectomies in some patients.

详细描述

Hepatobiliary imaging (HIDA) has an important role in the evaluation of the function and dynamics of the hepatobiliary system and the flow of bile to the gastrointestinal system. Contractility of the gallbladder is one of the functions that are uniquely evaluated using a HIDA scan. Poor contractility of the gallbladder can be the source of pain in many patients. Anatomic imaging studies like ultrasound, CT and/or MRI are usually normal in these patients.

Contractility of the gallbladder is evaluated during a HIDA scan by intravenous injection of cholecystokinin (CCK) a physiologic peptide enzyme produced in the duodenum in response to the presence of fatty meal which causes the gallbladder to contract and the sphincter of Oddi to relax, thus allowing the flow of bile from the gallbladder to the duodenum. CCK is usually administered during a HIDA scan intravenously after filling of the gallbladder with radioactive tracer to simulate the action of the endogenous CCK in contracting the gallbladder and relaxation of the sphincter of Oddi. Gallbladder ejection fraction (GBEF) in response to CCK injection is calculated using special computer software program. A normal gallbladder ejection fraction is equal to or greater than 35%. Alternative to CCK injection, the patient may be administered milk as a fatty drink that should stimulate a normal gallbladder to contract when it reaches the duodenum approximately 15-20 minutes after oral administration. Thus, gallbladder contractility may be evaluated during a HIDA scan either by injecting CCK intravenously or oral administration of milk. Poor contractility of the gallbladder may result in abdominal pain usually triggered by meals. However, in many patients with abdominal pain and a decreased gallbladder contractility as evaluated by IV CCK or milk may continue to suffer from pain even after surgical removal of the gallbladder . This suggests that abnormally decreased GBEF after CCK or milk stimulation may represent false abnormal finding resulting in unnecessary cholecystectomies in some of the patients. There are no reports in the literature that have used both intravenous CCK stimulation and oral milk administration together in the same patient.

This study aims to combine the use of IV CCK administration followed by oral milk during a HIDA scan to further stimulate the gallbladder contractility and decrease the number of false abnormal HIDA scans and unnecessary cholecystectomies in some patients.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients referred to a HIDA scan for evaluation of gallbladder function.
  • No evidence of gallbladder stones on any prior anatomic imaging studies.
  • Patients who are able to lie flat on the imaging table for an additional 30 min. of imaging after the standard of care 1.5 hour HIDA scan.

排除标准

  • Patients who are under 18 years of age.
  • Patients with evidence of gallbladder stones on other imaging modalities.
  • Patient allergic to milk or dairy products.
  • HIDA scan ordered to evaluate for acute cholecystitis.

研究组 & 干预措施

CCK then Milk

Experimental

CCK administered and HIDA scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.

干预措施: CCK (Biological)

CCK then Milk

Experimental

CCK administered and HIDA scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.

干预措施: Milk (Other)

结局指标

主要结局

Gallbladder Ejection Fraction

时间窗: 45 minutes after milk administration

Patient will receive CCK, be scanned, and the ejection fraction will be measured. Then milk will be administered, repeat scan and ejection fraction will be measured.

次要结局

  • Number of Participants Who Received Cholecystectomy(6 months)
  • Number of Participants Who Reported Abdominal Pain at 6 Months(6 months)

研究者

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

Isis W Gayed

Associate Professor of Radiology - Clinical

The University of Texas Health Science Center, Houston

研究点 (2)

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