Virtual Chromoendoscopy With Magnification in Coeliac Disease.
Optical Enhancement Virtual Chromoendoscopy With High-definition Optical Magnification for Duodenal Mucosa Characterization in Coeliac Disease Patients.
1 other identifier
observational
40
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMarch 31, 2022
March 1, 2022
1.2 years
October 15, 2021
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Six months
Interventions
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.
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.
Eligibility Criteria
Adult patients, naïve to GFD, with clinical suspicion of CD who underwent endoscopic assessment.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, 090505, Ecuador
Related Publications (7)
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.
PMID: 29807874RESULTGadermayr 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.
PMID: 29739614RESULTBonatto 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.
PMID: 27556094RESULTIacucci 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.
PMID: 27227112RESULTPenny 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.
PMID: 26995214RESULTIaniro 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.
PMID: 24379573RESULTDe 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.
PMID: 23983448RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Robles-Medranda, MD FASGE
Ecuadorian Institute of Digestive Diseases
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
November 2, 2021
Study Start
October 1, 2021
Primary Completion
December 1, 2022
Study Completion
January 1, 2023
Last Updated
March 31, 2022
Record last verified: 2022-03