Acceptability and Tolerability of Magnetic Assisted Capsule Endoscopy Compared to Gastroscopy

Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Feb 1, 2018

Keywords

ClinConnect Summary

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 (heig...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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