Plain English Summary
Background and study aims
Iron deficiency anaemia affects 2-5% of the adult population and accounts for between 4-13% of gastroenterology referrals as GI blood loss is considered the commonest cause in men and non-menstruating women. Single visit upper and lower endoscopic investigation is recommended. Capsule endoscopy is the accepted gold standard for small bowel investigation and is extremely well tolerated. How often the small bowel is responsible for blood loss is unknown and probably underestimated. This study aims to assess the prevalence of lesions in the entire gastrointestinal tract by endoscopy in patients with iron deficiency anaemia.
Who can participate?
Patients aged 18 to 80 who have been referred for conventional upper and lower GI investigation to investigate their iron deficiency anaemia
What does the study involve?
Participants receive two sachets of polyethylene glycol the evening before the procedure as per normal small bowel endoscopy. Before the procedure height, weight and waist/hip circumference are measured. Participants undergo a magnetically assisted capsule endoscopy procedure to examine the upper GI tract and the small bowel. The participant completes the pre-endoscopy section of the participant questionnaire before, and the post-endoscopy section after the procedure. The same procedure is also followed for the gastroscopy element of the study.
What are the possible benefits and risks of participating?
The study itself carries minimal risk. Capsule endoscopy has traditionally been used to investigate diseases of the small bowel, which can cause the small bowel to be narrowed and prevent the capsule from passing through in about 1 in a 200 cases. Therefore to ensure this risk is accounted for participants will be asked a number of questions to ensure that they have no history of small bowel diseases.
Where is the study run from?
1. Royal Hallamshire Hospital (UK)
2. Northern General Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2018 to September 2020
Who is funding the study?
ANKON Technologies
Who is the main contact?
Prof. Mark McAlindon
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark McAlindon
ORCID ID
http://orcid.org/0000-0003-0985-3643
Contact details
Department of Gastroenterology P Floor
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 (0)114 2712443
Mark.McAlindon@sth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
40125
Study information
Scientific title
Location of lesions responsible for blood loss in the gastrointestinal (GI) tract
Acronym
Study hypothesis
Is a magnetic controlled capsule endoscopy more effective than conventional gastroscopy when assessing the prevalence, nature and location of lesions in the gastrointestinal tract that may contribute to iron deficiency?
Ethics approval
North West - Preston Research Ethics Committee, Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, Tel: +44 (0)207 104 8196, +44 (0)207 104 8234, Email: nrescommittee.northwest-preston@nhs.net, 14/09/2018, ref: 18/NW/0588
Study design
Non-randomised; Interventional; Design type: Diagnosis, Imaging
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Gastrointestinal haemorrhage
Intervention
Patients who have been referred for conventional upper and lower GI investigation to investigate their iron deficiency anemia will be invited to undergo a magnetically assisted capsule endoscopy procedure to examine the upper GI tract and the small bowel.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause Iron deficiency anaemia, measured using magnetically assisted capsule endoscopy; Timepoint(s): end of study assessment
Secondary outcome measures
1. The diagnostic yield of the upper GI magnetic controlled capsule endoscopy compared with conventional gastroscopy following both procedures
2. Patient-reported tolerance of capsule endoscopy and gastroscopy measured using a questionnaire following both procedures
Overall trial start date
14/03/2018
Overall trial end date
01/09/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 18 years and over and up to but not exceeding 80 years
2. Patients presenting with IDA whom require gastroscopy and colonoscopy is indicated as per national guidelines
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Total final enrolment
100
Participant exclusion criteria
1. Patients under the age of 18 years
2. Patients over the age of 80 years
3. Active vomiting
4. Patients with a permanent pacemaker, implantable cardioverter-defibrillator or REVEAL device
5. Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators
6. Patients with dysphagia, odynophagia or known swallowing disorder
7. Patients with known Zenker’s diverticulum
8. Patients with suspected bowel obstruction or bowel perforation
9. Patients with prior bowel obstruction
10. Patients with gastroparesis or known gastric outlet obstruction
11. Patients with known Crohn’s disease
12. Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months
13. Patients who have received abdominopelvic radiotherapy treatment
14. Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
15. Patients that are pregnant or lactating
16. Patients with altered mental status that would limit their ability to swallow
17. Patients with allergy to conscious sedation or metoclopramide
18. Patients unwilling to swallow the capsule
19. Patients with known dementia affecting ability to consent
20. Patients who are unable to understand or speak English
21. Patients unable to provide written informed consent
Recruitment start date
25/10/2018
Recruitment end date
01/07/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Trial participating centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
Sheffield Teaching Hospital NHS Foundation Trust
Sponsor details
Luke Barron
Research Coordinator
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 2711899
ResearchAdministration@sth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Shanghai Ankon Technologies Co Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists aim to present the results of these findings to nation and international conferences such as the British Society of Gastroenterology Annual meeting. They also hope to disseminate the findings by submitting results for publication in peer-reviewed journals.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/09/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list