Celiac DiseaseNCT05103150
Virtual Chromoendoscopy With Magnification in Coeliac Disease.
An observational study of Celiac Disease, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). To the best of the knowledge of the authorship, there is no prospective study that has evaluated the accuracy of combining high-definition… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- High-definition white light endoscopy (HD-WLE) and HD-WLE plus I-Scan optical enhancement (OE) virtual chromoendoscopy with High-definition optical magnification (HD-OM)
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Oct 2021to 1 Jan 2023
- How long will I take part?
- 1 Day
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, naïve to GFD, with clinical suspicion of CD who underwent endoscopic assessment.
Who may be able to join
- Patients naïve to GFD;
- With clinical history suggestive of malabsorption (weight loss, chronic diarrhea, iron-deficiency, anemia, etc.);
- And serologic suspicion of CD as positive or borderline antiendomysial (normal values are absent for both IgA and IgG) and antitransglutaminase antibodies (normal values 0-10 U/mL).
Who cannot join
- Presence of severe gastrointestinal or systemic disease (e.g., chronic pancreatitis, liver cirrhosis, and blood coagulation disorders) impacts cardiovascular risk assessment.
- Presence of duodenal ulcer in the context of patients with upper gastrointestinal bleeding.
- History of any type of duodenal surgery.
- Pregnancy or nursing female.
- Refusal to participate in this observational trial.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505
About this study
Official title: Optical Enhancement Virtual Chromoendoscopy With High-definition Optical Magnification for Duodenal Mucosa Characterization in Coeliac Disease Patients.
High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). To the best of the knowledge of the authorship, there is no prospective study that has evaluated the accuracy of combining high-definition optical magnification (HD-OM) with i-Scan optical enhancement (OE) virtual chromoendoscopy for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies. This study pursues to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.
Read the detailed description
High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). In addition, HD-WLE findings depend on CD severity. The lesser the disease severity, the higher possibility of showing a normal HD-WLE appearance. Thus, sampling routine duodenal biopsies have been suggested. However, this is time-consuming, expensive, and maybe excessive in low-risk groups. Sampling routine duodenal biopsies could also be unsuccessful, obtaining normal biopsies.
Novel endoscopic techniques have played an exciting role in increasing the accuracy of macroscopic evaluation of duodenal villous patterns. There have been described retrospective and prospective studies using chromoendoscopy, narrow-band imaging, optical coherence tomography, water immersion, confocal laser endomicroscopy, high-resolution magnification endoscopy, capsule endoscopy, and I-scan technology. However, results are disjunct, with no consensus.
The iSCAN optical enhancementTM (OE) System (PENTAX Medical, Tokyo, Japan) virtual chromoendoscopy has been developed to improve the blood vessels' visibility, ducts of the glands, and surface structures in addition to the traditional iSCAN functions. High-definition optical magnification (HD-OM) endoscopes have been developed and can combine HD imaging with OM to produce detailed images with a magnification of up to 136X. This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa, enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy.
Prospective data have demonstrated that magnification endoscopy has superior diagnostic sensitivity in detecting villous atrophy compared to HD-WLE, being efficiently handled by all endoscopists. On another side, virtual chromoendoscopy has shown disjunct results across the literature. To the best of the knowledge of the authorship, there is no prospective study that has assessed the accuracy of combining HD-OM with i-Scan OE for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies.
This study pursues to better characterize duodenal mucosa through OE with HD-OM in gluten-free diet (GFD) naïve patients with CD suspicion to correlate these findings with histology. As a second aim, to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.
- Conditions
- Celiac Disease
- Being tested
- High-definition white light endoscopy (HD-WLE), HD-WLE plus I-Scan optical enhancement (OE) virtual chromoendoscopy with High-definition optical magnification (HD-OM)
- Keywords
- Celiac disease, Endoscopy, Gastrointestinal
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition white light endoscopy (HD-WLE)Diagnostic test
Evaluation of the duodenal mucosa with HD-WLE (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by one endoscopist, randomly assigned via esophagogastroduodenoscopy.
There were used the following standard endoscopic findings were: a) "scalloping" or dented aspect of the duodenal folds; b) submucosal vascular pattern; c) "mosaicism" or micronodular look of the mucosa; d) grooves and fissurations of the mucosa.
HD-WLE plus I-Scan optical enhancement (OE) virtual chromoendoscopy with High-definition optical magnification (HD-OM)Diagnostic test
Evaluation of the duodenal mucosa through upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves using a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode one and mode two without HD-OM to obtain an overview of the duodenal surface and identify any changes in the mucosa, then HD-OM will be implemented.
There were used OE criteria as previously validated by Cammarota et al: brightness, Ave/peak, blue, red, surface, contrast, and tone enhancement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Marsh's classification as revised by Oberhuber et al.
Histology findings will be recorded and graded according to Marsh's classification as revised by Oberhuber et al (Marsh 0, Marsh 1, Marsh 2, Marsh 3a, Marsh 3b, and Marsh 3c). HD-WLE and HD-OM findings will be correlated with Marsh's classification. Finally, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HD-WLE and HD-OM will be calculated, considering Marsh's classification as gold standard.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Robles-Medranda, MD FASGE, Principal investigator, Ecuadorian Institute of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103150
- Sponsor's protocol ID
- IECED-10142021
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raju SA, White WL, Lau MS, Mooney PD, Rees MA, Burden M, Ciacci C, Sanders DS. A comparison study between Magniview and high definition white light endoscopy in detecting villous atrophy and coeliac disease: A single centre pilot study. Dig Liver Dis. 2018 Sep;50(9):920-924. doi: 10.1016/j.dld.2018.03.037. Epub 2018 Apr 11.
PubMed 29807874Gadermayr M, Wimmer G, Kogler H, Vecsei A, Merhof D, Uhl A. Automated classification of celiac disease during upper endoscopy: Status quo and quo vadis. Comput Biol Med. 2018 Nov 1;102:221-226. doi: 10.1016/j.compbiomed.2018.04.020. Epub 2018 Apr 27.
PubMed 29739614Bonatto MW, Kotze L, Orlandoski M, Tsuchyia R, de Carvalho CA, Lima D, Kurachi G, Orso IR, Kotze L. Endoscopic evaluation of celiac disease severity and its correlation with histopathological aspects of the duodenal mucosa. Endosc Int Open. 2016 Jul;4(7):E767-77. doi: 10.1055/s-0042-108190. Epub 2016 Jun 29.
PubMed 27556094Iacucci M, Poon T, Gui XS, Subrata G. High definition i-SCAN endoscopy with water immersion technique accurately reflects histological severity of celiac disease. Endosc Int Open. 2016 May;4(5):E540-6. doi: 10.1055/s-0042-105955. Epub 2016 May 10.
PubMed 27227112Penny HA, Mooney PD, Burden M, Patel N, Johnston AJ, Wong SH, Teare J, Sanders DS. High definition endoscopy with or without I-Scan increases the detection of celiac disease during routine endoscopy. Dig Liver Dis. 2016 Jun;48(6):644-9. doi: 10.1016/j.dld.2016.02.009. Epub 2016 Feb 26.
PubMed 26995214Ianiro G, Gasbarrini A, Cammarota G. Endoscopic tools for the diagnosis and evaluation of celiac disease. World J Gastroenterol. 2013 Dec 14;19(46):8562-70. doi: 10.3748/wjg.v19.i46.8562.
PubMed 24379573De Luca L, Ricciardiello L, Rocchi MB, Fabi MT, Bianchi ML, de Leone A, Fiori S, Baroncini D. Narrow band imaging with magnification endoscopy for celiac disease: results from a prospective, single-center study. Diagn Ther Endosc. 2013;2013:580526. doi: 10.1155/2013/580526. Epub 2013 Aug 6.
PubMed 23983448
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Enhancement Virtual Chromoendoscopy With High-definition Optical Magnification for Duodenal Mucosa Characterization in Coeliac Disease Patients.
- ClinicalTrials.gov ID
- NCT05103150
- Acronym / sponsor ID
- IECED-10142021
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Endoscopy, Gastrointestinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 2 Nov 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.
High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). To the best of the knowledge of the authorship, there is no prospective study that has evaluated the accuracy of combining high-definition optical magnification (HD-OM) with i-Scan optical enhancement (OE) virtual chromoendoscopy for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies. This study pursues to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.
Detailed description
High-definition white light endoscopy (HD-WLE) does not usually allow the visualization of duodenal villous patterns and may be inaccurate for assessing coeliac disease (CD). In addition, HD-WLE findings depend on CD severity. The lesser the disease severity, the higher possibility of showing a normal HD-WLE appearance. Thus, sampling routine duodenal biopsies have been suggested. However, this is time-consuming, expensive, and maybe excessive in low-risk groups. Sampling routine duodenal biopsies could also be unsuccessful, obtaining normal biopsies.
Novel endoscopic techniques have played an exciting role in increasing the accuracy of macroscopic evaluation of duodenal villous patterns. There have been described retrospective and prospective studies using chromoendoscopy, narrow-band imaging, optical coherence tomography, water immersion, confocal laser endomicroscopy, high-resolution magnification endoscopy, capsule endoscopy, and I-scan technology. However, results are disjunct, with no consensus.
The iSCAN optical enhancementTM (OE) System (PENTAX Medical, Tokyo, Japan) virtual chromoendoscopy has been developed to improve the blood vessels' visibility, ducts of the glands, and surface structures in addition to the traditional iSCAN functions. High-definition optical magnification (HD-OM) endoscopes have been developed and can combine HD imaging with OM to produce detailed images with a magnification of up to 136X. This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa, enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy.
Prospective data have demonstrated that magnification endoscopy has superior diagnostic sensitivity in detecting villous atrophy compared to HD-WLE, being efficiently handled by all endoscopists. On another side, virtual chromoendoscopy has shown disjunct results across the literature. To the best of the knowledge of the authorship, there is no prospective study that has assessed the accuracy of combining HD-OM with i-Scan OE for evaluation of duodenal villous patterns in the context of CD suspicion. Combining both techniques can also guide better duodenal biopsies.
This study pursues to better characterize duodenal mucosa through OE with HD-OM in gluten-free diet (GFD) naïve patients with CD suspicion to correlate these findings with histology. As a second aim, to compare diagnostic accuracy between HD-WLE and HD-OM with OE using histology as the gold standard in detecting villous abnormalities in CD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, naïve to GFD, with clinical suspicion of CD who underwent endoscopic assessment.
Key inclusion criteria (3 listed)
- Patients naïve to GFD;
- With clinical history suggestive of malabsorption (weight loss, chronic diarrhea, iron-deficiency, anemia, etc.);
- And serologic suspicion of CD as positive or borderline antiendomysial (normal values are absent for both IgA and IgG) and antitransglutaminase antibodies (normal values 0-10 U/mL).
Key exclusion criteria (5 listed)
- Presence of severe gastrointestinal or systemic disease (e.g., chronic pancreatitis, liver cirrhosis, and blood coagulation disorders) impacts cardiovascular risk assessment.
- Presence of duodenal ulcer in the context of patients with upper gastrointestinal bleeding.
- History of any type of duodenal surgery.
- Pregnancy or nursing female.
- Refusal to participate in this observational trial.
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 |
|---|---|---|
| High-definition white light endoscopy (HD-WLE)Evaluation of the duodenal mucosa with HD-WLE (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by one endoscopist, randomly assigned via esophagogastroduodenoscopy. There were used the following standard endoscopic findings were: a) "scalloping" or dented aspect of the duodenal folds; b) submucosal vascular pattern; c) "mosaicism" or micronodular look of the mucosa; d) grooves and fissurations of the mucosa. | Diagnostic test | – |
| HD-WLE plus I-Scan optical enhancement (OE) virtual chromoendoscopy with High-definition optical magnification (HD-OM)Evaluation of the duodenal mucosa through upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves using a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode one and mode two without HD-OM to obtain an overview of the duodenal surface and identify any changes in the mucosa, then HD-OM will be implemented. There were used OE criteria as previously validated by Cammarota et al: brightness, Ave/peak, blue, red, surface, contrast, and tone enhancement. | Diagnostic test | – |
Primary outcome
Marsh's classification as revised by Oberhuber et al.
Time frame: Six months
Histology findings will be recorded and graded according to Marsh's classification as revised by Oberhuber et al (Marsh 0, Marsh 1, Marsh 2, Marsh 3a, Marsh 3b, and Marsh 3c). HD-WLE and HD-OM findings will be correlated with Marsh's classification. Finally, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HD-WLE and HD-OM will be calculated, considering Marsh's classification as gold standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Results publication: PubMed 29807874Raju SA, White WL, Lau MS, Mooney PD, Rees MA, Burden M, Ciacci C, Sanders DS. A comparison study between Magniview and high definition white light endoscopy in detecting villous atrophy and coeliac disease: A single centre pilot study. Dig Liver Dis. 2018 Sep;50(9):920-924. doi: 10.1016/j.dld.2018.03.037. Epub 2018 Apr 11.
- Results publication: PubMed 29739614Gadermayr M, Wimmer G, Kogler H, Vecsei A, Merhof D, Uhl A. Automated classification of celiac disease during upper endoscopy: Status quo and quo vadis. Comput Biol Med. 2018 Nov 1;102:221-226. doi: 10.1016/j.compbiomed.2018.04.020. Epub 2018 Apr 27.
- Results publication: PubMed 27556094Bonatto MW, Kotze L, Orlandoski M, Tsuchyia R, de Carvalho CA, Lima D, Kurachi G, Orso IR, Kotze L. Endoscopic evaluation of celiac disease severity and its correlation with histopathological aspects of the duodenal mucosa. Endosc Int Open. 2016 Jul;4(7):E767-77. doi: 10.1055/s-0042-108190. Epub 2016 Jun 29.
- Results publication: PubMed 27227112Iacucci M, Poon T, Gui XS, Subrata G. High definition i-SCAN endoscopy with water immersion technique accurately reflects histological severity of celiac disease. Endosc Int Open. 2016 May;4(5):E540-6. doi: 10.1055/s-0042-105955. Epub 2016 May 10.
- Results publication: PubMed 26995214Penny HA, Mooney PD, Burden M, Patel N, Johnston AJ, Wong SH, Teare J, Sanders DS. High definition endoscopy with or without I-Scan increases the detection of celiac disease during routine endoscopy. Dig Liver Dis. 2016 Jun;48(6):644-9. doi: 10.1016/j.dld.2016.02.009. Epub 2016 Feb 26.
- Results publication: PubMed 24379573Ianiro G, Gasbarrini A, Cammarota G. Endoscopic tools for the diagnosis and evaluation of celiac disease. World J Gastroenterol. 2013 Dec 14;19(46):8562-70. doi: 10.3748/wjg.v19.i46.8562.
- Results publication: PubMed 23983448De Luca L, Ricciardiello L, Rocchi MB, Fabi MT, Bianchi ML, de Leone A, Fiori S, Baroncini D. Narrow band imaging with magnification endoscopy for celiac disease: results from a prospective, single-center study. Diagn Ther Endosc. 2013;2013:580526. doi: 10.1155/2013/580526. Epub 2013 Aug 6.
- 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.
Carlos Robles-Medranda, MD FASGE principal investigator
Ecuadorian Institute of Digestive Diseases
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 Celiac Disease, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 5 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 31 Mar 2022. 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 Ecuador. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marsh's classification as revised by Oberhuber et al. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103150, which also lists 7 linked publications.
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 31 Mar 2022.