跳至主要内容
临床试验/NCT04408872
NCT04408872撤回不适用

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)3 个研究点 分布在 1 个国家开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
3
主要终点
Length of stay (LOS) at the emergency room

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 patients inevitably undergo further testing if EGD is inconclusive, which adds costs and prolongs emergency room length of stay (LOS).EUS has traditionally been used after EGD for a myriad of reasons that no longer apply. The investigators therefore propose a prospective pilot study to determine whether adding primary EUS to EGD can reduce LOS and resource utilisation in emergency room patients referred for EGD.

详细描述

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.

In experienced hands, diagnostic EUS is now as safe and as accurate as EGD for diagnosing mucosal pathology and takes approximately 1 minute longer.(1; 2) Previously published work by our group suggests that EUS may reduce resource consumption in patients with unexplained abdominal pain.(3) The investigators also showed that in refractory dyspepsia with normal EGD and CT, EUS identified signs of occult chronic pancreatitis in up to 20% of cases.(4) More recently, EUS was found to identify previously undiagnosed, potential causes of unexplained abdominal pain in up to 9% of patients, or at least provides the same, if not more information than EGD and abdominal US alone.(2; 5; 6)

There are no previous studies that have prospectively compared the yield of EGD and PEUS in emergency room patients. The investigators hypothesize that adding EUS to EGD ("primary EUS" [PEUS]) can safely and more efficiently diagnose or exclude significant gastro-intestinal and pancreatico-biliary pathology in emergency room patients in whom EGD has been requested. The investigators therefore propose a prospective pilot study to perform a preliminary analysis of the potential impact of PEUS on the ability to make an early GI diagnosis (EGID), length of stay (LOS) and resource utilisation in emergency room patients referred for EGD. If there is sufficient evidence of a clinically useful impact, an appropriately powered study to determine whether PEUS is clinically superior to EGD with respect to these variables will be performed.

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

性别
All
接受健康志愿者

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.

结局指标

主要结局

Length of stay (LOS) at the emergency room

时间窗: 48 hours

The primary outcome will be time (hours) to discharge, or admission (for a GI diagnosis) after receipt of the endoscopy (EGD or EUS) report by the consulting gastroenterologist.

次要结局

  • Complications during emergency room stay(96 hours)
  • Alternate procedures undergone during emergency room stay(48 hours)
  • Frequency of conversion to the alternate procedure (EGD to EUS, or EUS to EGD)(48 hours)

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

Gastroenterologist

Centre hospitalier de l'Université de Montréal (CHUM)

研究点 (3)

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