Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Endoscopy Concerns Score
研究概览
简要总结
Dyspepsia is a common presenting complaint that doctors have to manage and this is true both in the primary and secondary care setting. OGD is a useful test for investigating a variety of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.
The investigators wish to undertake a prospective study comparing acceptability and tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to general practice or the outpatients department with symptoms of dyspepsia who are referred for investigation are invited to take part in the study. Patients will undergo MACE prior to OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and acceptance of both procedures will be measured by means of using structured and validated, qualitative questionnaires. The aim is to assess for whether there is a significant difference between the perception and experience of both modalities.
详细描述
This is a prospective, single blinded, comparative trial of patient acceptability and tolerability of MACE and both transoral and transnasal gastroscopy in the investigation of dyspepsia.
The study will be conducted within Sheffield Teaching Hospitals. Recruitment will take place at the Sloan Medical Centre, the Royal Hallamshire Hospital or the Northern General Hospital during the consultation when patients present with dyspepsia requiring gastroscopy for investigation as per national guidelines. MACE will take place at the Sloan Medical Centre. Equipment for collecting demographics (height, weight etc) will be available. All the capsule equipment is stored and re-charged in this designated room. The case report files and computer data will be stored in this room that is secured by a locked door.
Gastroscopy will take place in the Endoscopy Departments, which are specially designed units for a variety of endoscopic tests, at the Royal Hallamshire Hospital and Northern General Hospital.
Patients are assessed in the Sloan Medical Centre or the Royal Hallamshire Hospital/Northern General Hospital outpatients department for their primary presenting complaints of dyspepsia. The study will be discussed with patients in those who satisfy the enrolment criteria and they will be provided by with the written study literature. If in agreement to enter the study, informed written consent will be obtained from the patient.
Prior to any investigation, the pre-MACE section of the questionnaire will be completed by the patient with the assistance of study team members. MACE will be performed at the Sloan Medical Centre; this will be in a dedicated room setup to accommodate the MACE procedure.The post-MACE section of the questionnaire will then be completed by the patient with the assistance of study team members. MACE will be preceded by obtaining measurements of height, weight and waist/hip circumference. The patient will then be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. Our previous study has shown excellent tolerance of this volume of water distension by patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
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
- 否
入选标准
- •Patients aged 18 years and over and up to but not exceeding 80 years
- •Patients presenting symptoms of dyspepsia whom require gastroscopy as per national guidelines
排除标准
- •Patients under the age of 18 years
- •Patients over the age of 80 years
- •Active vomiting
- •Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
- •Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
- •Patients with dysphagia, odynophagia or known swallowing disorder
- •Patients with known Zenker's diverticulum
- •Patients with suspected bowel obstruction or bowel perforation
- •Patients with prior bowel obstruction
- •Patients with gastroparesis or known gastric outlet obstruction
- •Patients with known Crohn's disease
- •Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months
- •Patients who have received abdominopelvic radiotherapy treatment
- •Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
- •Patients that are pregnant or lactating
- •Patients with altered mental status that would limit their ability to swallow
- •Patients with allergy to conscious sedation or metoclopramide
- •Patients unwilling to swallow the capsule
- •Patients with known dementia affecting ability to consent
- •Patients who are unable to understand or speak English
- •Patients unable to provide written informed consent
- •Patients with head and neck cancers
- •Patients who have had nasal surgery, eg. rhinnoplasty
- •Patients allergic to lidocaine, pheylephirine or midazolam
- •Patient with bleeding diathesis, on warfarin or have chronic liver disease
- •Patients reluctant to have gastroscopy by both oral or transnasal route
研究组 & 干预措施
magnetic assisted capsule endoscopy
All participants will undergo magnetic assisted capsule endoscopy at the sloan medical centre
干预措施: gastroscopy (Procedure)
magnetic assisted capsule endoscopy
All participants will undergo magnetic assisted capsule endoscopy at the sloan medical centre
干预措施: magnetic assisted capsule endoscopy (Device)
gastroscopy
All participants will undergo gastroscopy as standard of care at sheffield teaching hospitals
干预措施: gastroscopy (Procedure)
gastroscopy
All participants will undergo gastroscopy as standard of care at sheffield teaching hospitals
干预措施: magnetic assisted capsule endoscopy (Device)
结局指标
主要结局
Endoscopy Concerns Score
时间窗: procedure
Differences in the Endoscopy Concerns Score (ECS) when patients have magnetic assisted capsule endoscopy (MACE) and when they have conventional gastroscopy
次要结局
- Clinician rating of visualization of upper GI Tract(procedure)