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临床试验/NCT03432208
NCT03432208终止不适用

A Pilot Study to Assess the Potential Value of Adding Endoscopic Ultrasound (EUS) to Esophago-gastro-duodenoscopy (EGD) in Emergency Room Patients Referred for Egd

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年5月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
1
主要终点
time to GI diagnosis

研究概览

简要总结

Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many possible causes for their symptoms. These inevitably undergo further testing if EGD is inconclusive, which adds costs and inevitably prolongs emergency room length of stay (LOS).EUS has traditionally been used after EGD for a myriad of costs reasons that no longer apply. We therefore propose a prospective pilot study to determine whether PEUS can reduce LOS and resource utilisation in emergency room patients referred for EGD.

详细描述

A PILOT STUDY TO ASSESS THE POTENTIAL VALUE OF ADDING ENDOSCOPIC ULTRASOUND (EUS) TO ESOPHAGO-GASTRO-DUODENOSCOPY (EGD) IN EMERGENCY ROOM PATIENTS REFERRED FOR EGD

P.I.: Anand V. Sahai MD, MSc (EPID), FRCPC

BACKGROUND Emergency room patients referred for esophago-gastro-duodenoscopy (EGD) often have many possible causes for their symptoms. These inevitably undergo further testing if EGD is inconclusive, which adds costs and inevitably prolongs emergency room length of stay (LOS).

Endoscopic ultrasound (EUS) combines EGD with high-resolution ultrasound imaging of pancreas, liver and biliary system and is the best test to diagnose bile duct stones, early chronic pancreatitis, and small [<2cm] pancreatic cancers (all of which cannot be seen by regular ultrasound or CT scanning or MRI, yet are included in the differential diagnosis of EGD-negative abdominal pain).

EUS has traditionally been used after EGD, due to lack of availability, increased cost, and to increased risk due to larger scope diameter. However, the latest generation of EUS scopes have the same outer diameter as conventional gastroscopes, there is much wider availability of EUS in university and community hospital settings, and the cost per procedure is lower, due to increased procedural numbers and reduced maintenance costs.

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

  • •EGD requested by the consulting gastroenterologist
  • •Informed consent

排除标准

  • •Evidence of hemodynamic instability and/or ongoing active GI bleeding.
  • •Any suspicion of obstruction distal to the angle of Treitz.
  • •EGD or EUS cannot be performed before 12PM.
  • •Previous barium study, EGD, US, abdomino-pelvic CT, or abdomino-pelvic MRI within the last 6 months.

研究组 & 干预措施

ESOPHAGO-GASTRO-DUODENOSCOPY (EGD)

Active Comparator

GI consult Procedure performed is EGD

干预措施: GI consult (Procedure)

ENDOSCOPIC ULTRASOUND (EUS)

Experimental

GI consult Procedure performed is EUS

干预措施: GI consult (Procedure)

结局指标

主要结局

time to GI diagnosis

时间窗: 1 day

The primary outcome will be "time to GI diagnosis" (with T0 starting immediately after the procedure report is read and signed by the referring physician). A "GI diagnosis" is defined as diagnosis or confirmation of any condition sufficient to start treatment or to modify the existing therapeutic regimen.

次要结局

  • frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)(1 day)
  • number of subsequent imaging procedures other than endoscopy(1 day)
  • Complications(1 day)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Principal Investigator
主要研究者

A Sahai

Professeur Adjoint

Centre hospitalier de l'Université de Montréal (CHUM)

研究点 (1)

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