Gastro-Intestinal DisorderNCT04085211
Image-Enhanced Endoscopy in the Gastrointestinal Tract
An observational study of Gastro-Intestinal Disorder and Inflammatory Bowel Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract. This study aims to determine: (i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions (ii) if image-enhancement techniques could… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastro-Intestinal Disorder, Inflammatory Bowel Diseases, Gastro Esophageal Reflux
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to May 2022
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from a hospital setting, predominantly an outpatient setting where an endoscopic procedure is required part of routine care.
Who may be able to join
- Age > 18 years old
- Patient has mental capacity to consent
- Requires endoscopic procedure as part of routine care
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, King's College Hospital
London, SE5 9RS
Mehul Patel, MBBS, 02032996044
About this study
Official title: A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract
This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract.
This study aims to determine:
(i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions
(ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment
Read the detailed description
Endoscopic procedures are performed on a daily basis to visualise the gastrointestinal tract for diagnosis and intervention. The demand for procedures is growing, consequently increasing the number of additional investigations; for example, biopsies. Image enhancement techniques can be performed during procedures either digitally or through the use of dye. These techniques alter the qualities of the image e.g. colour, contrast and magnification. We believe these techniques have several potential benefits: (i) improve diagnostic accuracy (ii) filter appropriate selection of additional investigations to maximise diagnostic yield (iii) the potential to replace existing investigations which are costly and intricate.
Participants included in the study will have an endoscopic procedure as indicated for routine clinical care. On the day of the procedure (or before), a baseline assessment will be performed - symptom questionnaires, medical history and recording any relevant investigation results performed as part of routine care. Participants will have the endoscopic procedure as normal, with additional images and video obtained using different image enhancement techniques. Select patients will have follow-up for up to one year to determine relapse. The image enhancement technique findings will be compared to the gold standard investigation currently available as part of routine care for the condition of interest.
The study will look at a range of different image enhancement techniques: dye chromoendoscopy, blue laser imaging (BLI), linked colour imaging (LCI), narrow band imaging (NBI), image magnification and endocytoscopy. This will involve a range of gastrointestinal conditions.
Ethics Approval: favourable opinion was provided by the East Midlands - Derby research and ethics committee, reference: 19/EM/0167.
- Conditions
- Gastro-Intestinal Disorder, Inflammatory Bowel Diseases, Gastro Esophageal Reflux, Atrophic Gastritis, Neuroendocrine Tumors
- Keywords
- endoscopy
- Medical subject headings
- Digestive System Diseases, Inflammatory Bowel Diseases, Gastroesophageal Reflux, Gastritis, Atrophic, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease | Patients with an established diagnosis of ulcerative colitis or Crohn's Disease who require either a flexible sigmoidoscopy or colonoscopy as part of routine care (e.g. surveillance or staging disease activity) | |
| Patients with symptoms of gastro-oesophageal reflux disease | Patients with symptoms of gastro-oesophageal reflux disease requiring a gastroscopy as part of routine clinical care. | |
| Atrophic gastritis | Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes. | |
| Neuroendocrine Tumours | Patients with an established history of gastric neuroendocrine tumours requiring surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions
Identify specific features on NBI,BLI, LCI, magnification and endocytoscopy to accurately diagnose / grade severity of a range of conditions when compared to the gold standard diagnostic investigation e.g. biopsy, pH impedance testing
Measured: 8 weeks
Secondary outcomes (2)
Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.
Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.
Measured: 12 months
median duration for image enhanced endoscopy procedures
median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Jul 2019
- Primary completionFeb 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bu'Hussain Hayee, PhD, MBBS,, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085211
- Sponsor's protocol ID
- KCH19-069
- Status last verified
- Nov 2020
- First submitted
- 9 Sep 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract
- ClinicalTrials.gov ID
- NCT04085211
- Acronym / sponsor ID
- KCH19-069
- Conditions
- Gastro-Intestinal Disorder, Inflammatory Bowel Diseases, Gastro Esophageal Reflux, Atrophic Gastritis, Neuroendocrine Tumors
- Keywords
- endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Sep 2019 (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.
This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract.
This study aims to determine:
(i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions
(ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment
Detailed description
Endoscopic procedures are performed on a daily basis to visualise the gastrointestinal tract for diagnosis and intervention. The demand for procedures is growing, consequently increasing the number of additional investigations; for example, biopsies. Image enhancement techniques can be performed during procedures either digitally or through the use of dye. These techniques alter the qualities of the image e.g. colour, contrast and magnification. We believe these techniques have several potential benefits: (i) improve diagnostic accuracy (ii) filter appropriate selection of additional investigations to maximise diagnostic yield (iii) the potential to replace existing investigations which are costly and intricate.
Participants included in the study will have an endoscopic procedure as indicated for routine clinical care. On the day of the procedure (or before), a baseline assessment will be performed - symptom questionnaires, medical history and recording any relevant investigation results performed as part of routine care. Participants will have the endoscopic procedure as normal, with additional images and video obtained using different image enhancement techniques. Select patients will have follow-up for up to one year to determine relapse. The image enhancement technique findings will be compared to the gold standard investigation currently available as part of routine care for the condition of interest.
The study will look at a range of different image enhancement techniques: dye chromoendoscopy, blue laser imaging (BLI), linked colour imaging (LCI), narrow band imaging (NBI), image magnification and endocytoscopy. This will involve a range of gastrointestinal conditions.
Ethics Approval: favourable opinion was provided by the East Midlands - Derby research and ethics committee, reference: 19/EM/0167.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | –Patients with an established diagnosis of ulcerative colitis or Crohn's Disease who require either a flexible sigmoidoscopy or colonoscopy as part of routine care (e.g. surveillance or staging disease activity) |
| Patients with symptoms of gastro-oesophageal reflux disease | – | –Patients with symptoms of gastro-oesophageal reflux disease requiring a gastroscopy as part of routine clinical care. |
| Atrophic gastritis | – | –Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes. |
| Neuroendocrine Tumours | – | –Patients with an established history of gastric neuroendocrine tumours requiring surveillance |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from a hospital setting, predominantly an outpatient setting where an endoscopic procedure is required part of routine care.
Key inclusion criteria (3 listed)
- Age > 18 years old
- Patient has mental capacity to consent
- Requires endoscopic procedure as part of routine care
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions
Time frame: 8 weeks
Identify specific features on NBI,BLI, LCI, magnification and endocytoscopy to accurately diagnose / grade severity of a range of conditions when compared to the gold standard diagnostic investigation e.g. biopsy, pH impedance testing
2 secondary outcomes
Specific image enhancement findings to predict relapse for patients with inactive inflammatory bowel disease.
Time frame: 12 months
median duration for image enhanced endoscopy procedures
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Bu'Hussain Hayee, PhD, MBBS, principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-Intestinal Disorder and Inflammatory Bowel Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 1 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 30 Nov 2020. 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 United Kingdom. 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 Mehul Patel, MBBS, BSc (02032996044, mehul.patel4@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive predictive value of specific endoscopic image enhancement findings to diagnose or stage the severity of different gastrointestinal conditions (time frame: 8 weeks). 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 30 Nov 2020.