Location of lesions responsible for blood loss in the GI tract
| ISRCTN | ISRCTN85978758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85978758 |
| Secondary identifying numbers | CPMS 40125 |
- Submission date
- 28/01/2019
- Registration date
- 31/01/2019
- Last edited
- 03/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 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 April 2023
Who is funding the study?
ANKON Technologies
Who is the main contact?
Prof. Mark McAlindon, mark.mcalindon@nhs.net
Contact information
Scientific
Department of Gastroenterology P Floor
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
 ORCID ID |
0000-0003-0985-3643 |
|---|---|
| Phone | +44 (0)7766220125 |
| mark.mcalindon@nhs.net |
Study information
| Study design | Non-randomized; Interventional; Design type: Diagnosis, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Location of lesions responsible for blood loss in the gastrointestinal (GI) tract |
| Study acronym | BLITGIT |
| Study objectives | 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(s) | Approved 14/09/2018, 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, ref: 18/NW/0588 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 14/03/2018 |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Total final enrolment | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/10/2018 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sheffield
S10 2JF
United Kingdom
Sheffield
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
Luke Barron
Research Coordinator
Northern General Hospital
Herries Road
Sheffield
S5 7AU
England
United Kingdom
| Phone | +44 (0)114 2711899 |
|---|---|
| ResearchAdministration@sth.nhs.uk | |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/12/2024: The intention to publish date was changed from 01/11/2024 to 01/01/2025.
01/05/2024: Contact details updated. The intention to publish date was changed from 31/01/2024 to 01/11/2024.
02/03/2023: Acronym added.
21/07/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2021 to 31/01/2023.
2. The overall end date was changed from 01/09/2021 to 30/04/2023.
3. The intention to publish date was changed from 01/09/2022 to 31/01/2024.
4. The plain English summary was updated to reflect these changes.
The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2020 to 01/07/2021.
2. The overall end date was changed from 01/09/2020 to 01/09/2021.
3. The intention to publish date was changed from 01/09/2021 to 01/09/2022.
4. The plain English summary was updated to reflect these changes.
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.
