Condition category
Digestive System
Date applied
28/01/2019
Date assigned
31/01/2019
Last edited
22/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

22/03/2019: The condition has been changed from "Specialty: Gastroenterology, Primary sub-specialty: Endoscopy and imaging; Health Category: Oral and Gastrointestinal; Disease/Condition: Other diseases of intestines" to "Gastrointestinal haemorrhage" following a request from the NIHR.