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This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.
The ultimate goal of endoscopy will be the 'optical biopsy' i.e. forgoing the need to take histological samples to make a diagnosis in order to reduce complication rates, cost and time. There are a number of imaging techniques which promise to improve our diagnostic rates for pathology, but there have been few comparative studies.
This is randomized controlled parallel trial in a 1:1 ratio with examination of the upper gastrointestinal tract with WLE followed by either NBI or iscan.
(Note: Prior to commencement of the study, technical issues and operational changes in our organisation forced the removal of the Pentax 'i-scan' endoscopes. Recruitment to this arm was anticipated, but was ultimately not possible.)
Patients attending the department for routine examinations for dyspepsia and abdominal pain will be randomised into 2 study arms (1WLE and NBI, and the other - WLE and iscan).
The investigator carrying out the procedure will be blinded to the indication for the procedure until a full examination with both white light endoscopy and either NBI or iscan has been used as this could lead to bias. They will determine if H pylori is present, and if so the severity of infection with WLE and again with either NBI or iscan depending on their study arm. Histopathological confirmation of H pylori and an assessment to the degree of infection will be assessed with samples taken using the updated Sydney system (5 gastric samples from different parts of the stomach).
The endoscopists reviewing the images will be blinded to all patient information and indications throughout the study period. Questionnaires will then be given to the endoscopists to determine what endoscopic features led them to their diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow band imaging | Placebo Comparator | Narrow band imaging function (Olympus endoscopes) |
|
| i-scan imaging | Experimental | i-scan imaging (Pentax endoscopes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-scan | Device | i-scan function is located on the head of the Pentax endoscopes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Diagnosis of Helicobacter Pylori Using Imaging Modality | The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques | 1 year |
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Inclusion Criteria:
• All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Teare | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | Greater London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34353822 | Derived | Glover B, Teare J, Patel N. Assessment of Helicobacter pylori status by examination of gastric mucosal patterns: diagnostic accuracy of white-light endoscopy and narrow-band imaging. BMJ Open Gastroenterol. 2021 Aug;8(1):e000608. doi: 10.1136/bmjgast-2021-000608. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Narrow Band Imaging | Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Narrow Band Imaging | Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Diagnosis of Helicobacter Pylori Using Imaging Modality | The endoscopic assessment of the presence of H pylori using standard endoscopy plus NBI will be compared to histological assessment. Inter-observer variability of assessment of the presence of H pylori will be compared between endoscopic imaging techniques | All patients presenting for endoscopy who were recruited to the study. | Posted | Count of Participants | Participants | 1 year |
|
|
1 year
Patients developing adverse events were to be identified either at the time of endoscopy, or on review of patient records at the time of study reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narrow Band Imaging | Narrow band imaging function (Olympus endoscopes) narrow band imaging: narrow band imaging function is located on the head of Olympus endoscopes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Julian Teare | Imperial College London | 02033126666 | j.teare@ic.ac.uk |
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| narrow band imaging |
| Device |
narrow band imaging function is located on the head of Olympus endoscopes |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 153 |
| 0 |
| 153 |
| 0 |
| 153 |
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| D008919 |
| Investigative Techniques |