Iron Deficiency AnemiaA-MACENCT04840433
Location of Lesions Responsible for Blood Loss in the Gastrointestinal (GI) Tract
A study testing MACE in people with Iron Deficiency Anemia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to identify the prevalence, nature and location of lesions in the GI tract that may contribute to iron deficiency anaemia and compare diagnostic yied of the upper GI magnetic controlled capsule endoscopy with conventional gastroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- MACE
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years and over and up to but not exceeding 80 years
- Patients presenting with IDA whom require gastroscopy and colonoscopy as per national guidelines (1)
Who cannot join
- Patients who have contraindications to gastroscopy or colonoscopy
- 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
Show all 22Show fewer
- 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, polyethylene glycol 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
felix sia, 26370428, felixsia@cuhk.edu.hk
About this study
The purpose of this study is to identify the prevalence, nature and location of lesions in the GI tract that may contribute to iron deficiency anaemia and compare diagnostic yied of the upper GI magnetic controlled capsule endoscopy with conventional gastroscopy.
Read the detailed description
Iron deficiency anaemia (IDA) affects 2-5% of men and post-menopausal women (1). It is thought to occur as a consequence of gastrointestinal blood loss in the majority of cases. Studies suggest that gastroscopy identifies a possible cause in 25-58 % and colonoscopy in 25-33 % of cases. Because pathologies in both upper and lower gastrointestinal tract occur simultaneously in up to 26% of cases, current United Kingdom guidelines recommend both gastroscopy and colonoscopy for patients with IDA.
Wireless capsule endoscopy (CE) is a non-invasive form of endoscopy using a swallowable pill camera which produces images which can be viewed as a video. It is used routinely in clinical practice to examine the small bowel and colon and a role in upper GI investigation is emerging. We have experience of upper GI capsule endoscopy in over 100 patients who have declined conventional gastroscopy using a protocol involving positional change to move a capsule around a water-filled stomach (Ching et al., submitted for publication. It is much better tolerated than conventional endoscopy which requires oral or anal intubation, often following the administration of intravenous sedation and analgesia and incurs a small risk of perforation.Pathology in the small bowel was historically considered to account for only 5% of all gastrointestinal causes of anaemia . Consequently, current guidelines recommend small bowel capsule endoscopy only when IDA has recurred after treatment. However, it is accepted that as many as 30 % of patients with IDA undergoing bidirectional endoscopy have no significant abnormality identified, raising the possibility that the cause is located in the small bowel. The studies which identified that only 5% of IDA was due to small bowel pathology used radiological methods of small bowel imaging, before the advent of CE. Meta-analyses now show significantly better diagnostic yields of CE compared to small bowel radiology in patients with IDA (42% and 6%, respectively).
Although mostly performed in patients with recurrent or refractory (as opposed to first presentation of) anaemia, CE studies show a diagnostic yield of small bowel pathology in 66% and a tumour detection rate of as much as 10% . Even in patients of less than 50 years of age, 5% of patients are found to have tumours. Given the uncertainties about which pathologies cause anaemia, the failure to identify a cause using conventional bidirectional endoscopy in 30% and the availability of a highly sensitive, well tolerated small bowel investigative tool, our primary aim is to determine the incidence, nature and location of pathology in the gastrointestinal tract by performing small bowel capsule endoscopy in patients referred for gastroscopy and colonoscopy for the investigation of IDA.
Prior to passage through the pylorus and small bowel, capsules can now be moved around the stomach using a joystick-controlled robot magnet (Ankon Technologies, Shanghai, China). A multicentre study using this device showed a 90% sensitivity in the detection of gastric focal lesions compared to gastroscopy, irrespective of size or location of the lesion. We have also demonstrated that the diagnostic ability of capsules moved around the stomach either using simple patient positional change or external handheld magnets is comparable to gastroscopy. Patient tolerance significantly favoured CE in these studies and no patient suffered adverse effects. The diagnostic yield using magnetically assisted CE (MACE) of the upper gastrointestinal tract will be compared with gastroscopy as a secondary outcome measure in this study of patients with IDA.
Overall, this study aims to report on the prevalence of lesions in entire gastrointestinal tract by endoscopy in patients with IDA. This is novel as there has been no such study reporting pan enteric pathology by endoscopy in unselected patients with iron deficiency since the advent of CE in 2000. This is important because uncertainty about the likelihood that certain upper gastrointestinal and colonic pathologies, such as oesophagitis, gastritis, diverticulosis and colonic polyps, are the cause of IDA, is widely acknowledged. In up to 25% of patients synchronous upper and lower GI pathologies are found on gastroscopy and colonoscopy, but we are unsure of the rates and significance of synchronous small bowel pathologies in those deemed to have a cause found on gastroscopy or colonoscopy. If there are significant synchronous pathologies in the small bowel it may be that small bowel CE should become part of first line investigation. Furthermore, should MACE prove to be sensitive in upper GI pathology detection when compared to gastroscopy, it may have a role in investigating the stomach and small bowel simultaneously.
- Conditions
- Iron Deficiency Anemia
- Being tested
- MACE
- Keywords
- magnetically assisted capsule endoscopy
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACEDevice
Using magnetically assisted capsule endoscopy to examine oesophagus and stomach
| Study group | Role | What they receive |
|---|---|---|
| MACE | Experimental | Patients will receive MACE for IDA. Receives: Device: MACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA
Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA
Measured: 1.5 years
Secondary outcomes (2)
Comparison of diagnostic performance between MACE and gastroscopy in the upper GI tract in detecting lesions that cause IDA
Comparison of diagnostic performance between MACE and gastroscopy in the upper GI tract in detecting lesions that cause IDA
Measured: 1.5 years
Comparison of patient acceptability of MACE and gastroscopy by patient questionnaire
Comparison of patient acceptability of MACE and gastroscopy by patient questionnaire
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start12 Apr 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will be invited to have MACE before their endoscopy and colonoscopy.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Tin Long Wong, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840433
- Sponsor's protocol ID
- 2020.370
- Acronym
- A-MACE
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location of Lesions Responsible for Blood Loss in the Gastrointestinal (GI) Tract
- ClinicalTrials.gov ID
- NCT04840433
- Acronym / sponsor ID
- A-MACE / 2020.370
- Conditions
- Iron Deficiency Anemia
- Keywords
- magnetically assisted capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the prevalence, nature and location of lesions in the GI tract that may contribute to iron deficiency anaemia and compare diagnostic yied of the upper GI magnetic controlled capsule endoscopy with conventional gastroscopy.
Detailed description
Iron deficiency anaemia (IDA) affects 2-5% of men and post-menopausal women (1). It is thought to occur as a consequence of gastrointestinal blood loss in the majority of cases. Studies suggest that gastroscopy identifies a possible cause in 25-58 % and colonoscopy in 25-33 % of cases. Because pathologies in both upper and lower gastrointestinal tract occur simultaneously in up to 26% of cases, current United Kingdom guidelines recommend both gastroscopy and colonoscopy for patients with IDA.
Wireless capsule endoscopy (CE) is a non-invasive form of endoscopy using a swallowable pill camera which produces images which can be viewed as a video. It is used routinely in clinical practice to examine the small bowel and colon and a role in upper GI investigation is emerging. We have experience of upper GI capsule endoscopy in over 100 patients who have declined conventional gastroscopy using a protocol involving positional change to move a capsule around a water-filled stomach (Ching et al., submitted for publication. It is much better tolerated than conventional endoscopy which requires oral or anal intubation, often following the administration of intravenous sedation and analgesia and incurs a small risk of perforation.Pathology in the small bowel was historically considered to account for only 5% of all gastrointestinal causes of anaemia . Consequently, current guidelines recommend small bowel capsule endoscopy only when IDA has recurred after treatment. However, it is accepted that as many as 30 % of patients with IDA undergoing bidirectional endoscopy have no significant abnormality identified, raising the possibility that the cause is located in the small bowel. The studies which identified that only 5% of IDA was due to small bowel pathology used radiological methods of small bowel imaging, before the advent of CE. Meta-analyses now show significantly better diagnostic yields of CE compared to small bowel radiology in patients with IDA (42% and 6%, respectively).
Although mostly performed in patients with recurrent or refractory (as opposed to first presentation of) anaemia, CE studies show a diagnostic yield of small bowel pathology in 66% and a tumour detection rate of as much as 10% . Even in patients of less than 50 years of age, 5% of patients are found to have tumours. Given the uncertainties about which pathologies cause anaemia, the failure to identify a cause using conventional bidirectional endoscopy in 30% and the availability of a highly sensitive, well tolerated small bowel investigative tool, our primary aim is to determine the incidence, nature and location of pathology in the gastrointestinal tract by performing small bowel capsule endoscopy in patients referred for gastroscopy and colonoscopy for the investigation of IDA.
Prior to passage through the pylorus and small bowel, capsules can now be moved around the stomach using a joystick-controlled robot magnet (Ankon Technologies, Shanghai, China). A multicentre study using this device showed a 90% sensitivity in the detection of gastric focal lesions compared to gastroscopy, irrespective of size or location of the lesion. We have also demonstrated that the diagnostic ability of capsules moved around the stomach either using simple patient positional change or external handheld magnets is comparable to gastroscopy. Patient tolerance significantly favoured CE in these studies and no patient suffered adverse effects. The diagnostic yield using magnetically assisted CE (MACE) of the upper gastrointestinal tract will be compared with gastroscopy as a secondary outcome measure in this study of patients with IDA.
Overall, this study aims to report on the prevalence of lesions in entire gastrointestinal tract by endoscopy in patients with IDA. This is novel as there has been no such study reporting pan enteric pathology by endoscopy in unselected patients with iron deficiency since the advent of CE in 2000. This is important because uncertainty about the likelihood that certain upper gastrointestinal and colonic pathologies, such as oesophagitis, gastritis, diverticulosis and colonic polyps, are the cause of IDA, is widely acknowledged. In up to 25% of patients synchronous upper and lower GI pathologies are found on gastroscopy and colonoscopy, but we are unsure of the rates and significance of synchronous small bowel pathologies in those deemed to have a cause found on gastroscopy or colonoscopy. If there are significant synchronous pathologies in the small bowel it may be that small bowel CE should become part of first line investigation. Furthermore, should MACE prove to be sensitive in upper GI pathology detection when compared to gastroscopy, it may have a role in investigating the stomach and small bowel simultaneously.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be invited to have MACE before their endoscopy and colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| MACE | Experimental | Device: MACEPatients will receive MACE for IDA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients aged 18 years and over and up to but not exceeding 80 years
- Patients presenting with IDA whom require gastroscopy and colonoscopy as per national guidelines (1)
Key exclusion criteria (22 listed)
- Patients who have contraindications to gastroscopy or colonoscopy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACEUsing magnetically assisted capsule endoscopy to examine oesophagus and stomach | Device | MACE |
Primary outcome
Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA
Time frame: 1.5 years
Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA
2 secondary outcomes
Comparison of diagnostic performance between MACE and gastroscopy in the upper GI tract in detecting lesions that cause IDA
Time frame: 1.5 years
Comparison of patient acceptability of MACE and gastroscopy by patient questionnaire
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MACE in people with Iron Deficiency Anemia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Sia (26370428, felixsia@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and nature of lesions in the upper GI tract, small bowel and colon that cause IDA (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.