跳至主要内容
临床试验/NCT02282852
NCT02282852已完成不适用

Randomised Comparison of a Standard Protocol Using Metoclopramide Versus a Hand Held Magnet to Enhance Gastric Emptying of the Small Bowel Capsule.

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Duration of time taken for camera capsule to enter duodenum.

研究概览

简要总结

Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. The procedure is safe and noninvasive, the main risk being capsule retention occurring in approximately 2% of procedures. Other problems such as incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric emptying, slow small bowel transit, faulty equipment and poor bowel preparation.

Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime' viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an intramuscular prokinetic injection if this fails. This approach has disadvantages since an intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly used for this purpose, has a risk of acute dystonic reactions particularly in young patients.

Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the capsule in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled study comparing a standard protocol for small bowel capsule endoscopy against a hand held magnet and positional change protocol to enhance gastric emptying of the wireless capsule.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 20 years or over
  • •Patients attending hospital for small bowel endoscopy examination

排除标准

  • •Patients under the age of 20 years
  • •Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
  • •Patients with any electronic/magnetic/mechanically controlled devices
  • •Patients that are pregnant
  • •Patients who are unable to understand or speak English

研究组 & 干预措施

Wireless Capsule Endoscopy

Experimental

Wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. A small pill-sized capsule contianing a camera is swallowed by the patient. The procedure is safe and non-invasive. Normally, the pill camera travels through the gut an exits the bowel via natural means. In a small number of cases the capsule is maintained. If the capsule is still in the stomach, mobilisation is encouraged followed by an intramuscular pro-kinetic injection if this fails.

干预措施: Wireless Capsule Endoscopy (Device)

Magnetically steerable capsule endoscopy

Active Comparator

A handheld magnet (manufactured by Intromedic Ltd.) has been developed to allow some control of the pill camera (that contains a small amount of magnetic material) in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication.

干预措施: Magnetically steerable capsule endoscopy (Device)

结局指标

主要结局

Duration of time taken for camera capsule to enter duodenum.

时间窗: Baseline

Completion rate of small bowel endoscopy examination

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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