An interventional study of i-scan and narrow band imaging in Gastritis, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic
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.
197 studies on the registry are indexed under Gastritis; 42 are open to participants now.
This study's enrollment of 157 is below the median of 191 across 114 interventional studies indexed under Gastritis.
Browse Gastritis studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Narrow band imaging function (Olympus endoscopes)
Device: narrow band imaging
i-scan imaging (Pentax endoscopes)
Device: i-scan
i-scan function is located on the head of the Pentax endoscopes
narrow band imaging function is located on the head of Olympus endoscopes
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
Time frame: 1 year
| Milestone | Narrow Band Imaging |
|---|---|
| Started | 157 |
| Completed | 153 |
| Not completed | 4 |
| Withdrew: Endoscopy could not be completed | 4 |
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
| Participants | Narrow Band Imaging |
|---|---|
| H Pylori Positive | 28 |
| H Pylori Negative | 125 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Narrow Band Imaging | 0/153 (0%) | 0/153 (0%) | 0/153 (0%) |
| Age, Categorical(Participants) | Narrow Band Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 106 |
| >=65 years | 47 |
| Age, Continuous(years) | Narrow Band Imaging |
|---|---|
| Mean | 54.2 ± 16.8 |
| Sex: Female, Male(Participants) | Narrow Band Imaging |
|---|---|
| Female | 87 |
| Male | 66 |
| Region of Enrollment(Participants) | Narrow Band Imaging |
|---|---|
| United Kingdom | 153 |
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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