Loading search results
Mucosal and Minimal Injuries Detected Through Digital Chromoendoscopy Using Optical Enhancement System™ Associated to High Definition Plus Optical Magnification in Non Erosive Gastroesophageal Reflux Disease
Sponsor study identifier
observational
100
1 country
1
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)White light endoscopy remains the gold standard technique to evaluate gastrointestinal tract. Gastroesophageal Reflux Disease (GERD) is defined as presence of reflux symptoms (heartburn and regurgitation) associated or not with lesions in esophageal mucosa. Based on findings at videoendoscopy GERD patients can have a complicated reflux disease (erosive esophagitis) or not and be considered as a non erosive reflux disease (NERD). 60% of GERD patients have normal endoscopy (NERD) and requires further studies to achieve a definitive diagnosis. Based on this fact is that the study will be focus on NERD patients. Recently an image-enhanced endoscopic technology using a pre-processor band-limited light called Optical Enhancement system (OE system™), was developed (Pentax Medical). This new technology combines digital signal processing with optical filters that limit the spectral characteristics of the illumination light. The new innovated optical filters achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm, 540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with different OE filters (Mode 1 and Mode 2). Mode 1 is designed to improve visualization of microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color. In addition, new scopes has been developed which combines high definition images with optical magnification called Magniview™. These scopes increase the image up to 136 times with a better quality of image than standard scopes without optical zoom. Sharma et al. evaluated esophageal changes in NERD patients using a similar pre-processor filter called Narrow Band Imaging (NBI). They found that a significantly higher proportion of patients with NERD had an increased number, dilation and tortuosity of the microscopic intrapapillary capillary loops (IPCLs), and were considered the best predictors for diagnosing NERD. They used optical chromoendoscopy technology (NBI) associated to magnification scopes (Olympus GIF Q240Z, 115x), but they did not evaluated if the contribution with this technology to the observations found in GERD patients were as a result of the NBI or the magnification scopes. The investigators opinion is that chromoendoscopy is useful but is the magnification what makes up the difference.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 9, 2015
Actual (reported)October 14, 2015
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)Digital chromoendoscopy and optical magnification in the diagnosis of intrapapillary loops (IPCLs) in esophagus. Number of participants with increased number of IPCLs, dilatation or tortuosity of IPCLs
two months
Number of patients in whom the minimal esophageal changes are diagnosed by the digital chromoendoscopy without using the magnification, or with the magnification without using the digital chromoendoscopy or using both.
two months
Number of patients with increased number, dilatation or tortuosity of the intrapapilary loops on endoscopic image and have a positive biopsy for inflammation of mucosa.
two months
(Digital chromoendoscopy with Optical Enhancement and without magnification; Digital chromoendoscopy with Optical Enhancement and with magnification; optical magnification without Digital chromoendoscopy: Optical Enhancement) Patients with reflux symptoms, without endoscopic lesions on the upper endoscopy with high definition white light or I-Scan and a positive ph-impedanciometry for reflux
(Digital chromoendoscopy with Optical Enhancement and without magnification; Digital chromoendoscopy with Optical Enhancement and with magnification; optical magnification without Digital chromoendoscopy: Optical Enhancement) Patients with reflux symptoms, without endoscopic lesions on the upper endoscopy with high definition white light or I-Scan and a negative ph-impedanciometry for reflux
A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement (Pentax Video Processor EPK-i7010; HOYA Co. Tokyo, Japan)
Patients that had reflux symptoms (heartburn and regurgitation) and 8 or more points at the Spanish version of GERD questionnaire validated by Zavala-González et al. underwent an upper videoendoscopy using initially high definition white light and then digital chromoendoscopy (I-Scan™) in the three different image algorithms. If the esophagus was normal and no changes were seen by these two techniques, they were considered as NERD patients and a pH-impedanciometry was performed as gold standard study, in order to diagnosis reflux disease. We considered a GERD diagnosis with more than 73 episodes of reflux in 24 hours or acid exposure time abnormal with ph\<4 measured in more than 4,2%of the time over 24 hours.
Ecuadorian Institute of Digestive Diseases, Omnihospital
Guayaquil, Guayas, 090505, Ecuador
Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
Kasap E, Zeybel M, Asik G, Ayhan S, Yuceyar H. Correlation among standard endoscopy, narrow band imaging, and histopathological findings in the diagnosis of nonerosive reflux disease. J Gastrointestin Liver Dis. 2011 Jun;20(2):127-30.
histological biopsies from esophagus
Carlos A Robles-Medranda, MD
Ecuadorian Institute of Digestive Diseases
100 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2015
First Posted
October 14, 2015
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement associated with an optical magnification using the scope called magniview (PENTAX Medical EG-2990Zi)
A endoscopic visualization of the mucosa using optical magnification without the use of the pre-processor filter called Optical enhancement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Zentilin P, Savarino V, Mastracci L, Spaggiari P, Dulbecco P, Ceppa P, Savarino E, Parodi A, Mansi C, Fiocca R. Reassessment of the diagnostic value of histology in patients with GERD, using multiple biopsy sites and an appropriate control group. Am J Gastroenterol. 2005 Oct;100(10):2299-306. doi: 10.1111/j.1572-0241.2005.50209.x.
Kim MS, Choi SR, Roh MH, Lee JH, Jang JS, Kim BG, Kim SO, Han JS, Hsing CT. Efficacy of I-scan endoscopy in the diagnosis of gastroesophageal reflux disease with minimal change. Clin Endosc. 2011 Sep;44(1):27-32. doi: 10.5946/ce.2011.44.1.27. Epub 2011 Sep 30.
Zavala-Gonzales MA, Azamar-Jacome AA, Meixueiro-Daza A, Ramos A, J JR, Roesch-Dietlen F, Remes-Troche JM. Validation and diagnostic usefulness of gastroesophageal reflux disease questionnaire in a primary care level in Mexico. J Neurogastroenterol Motil. 2014 Oct 30;20(4):475-82. doi: 10.5056/jnm14014.
Kandulski A, Weigt J, Caro C, Jechorek D, Wex T, Malfertheiner P. Esophageal intraluminal baseline impedance differentiates gastroesophageal reflux disease from functional heartburn. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1075-81. doi: 10.1016/j.cgh.2014.11.033. Epub 2014 Dec 9.
Dent J, Armstrong D, Delaney B, Moayyedi P, Talley NJ, Vakil N. Symptom evaluation in reflux disease: workshop background, processes, terminology, recommendations, and discussion outputs. Gut. 2004 May;53 Suppl 4(Suppl 4):iv1-24. doi: 10.1136/gut.2003.034272.
Sharma P, Wani S, Bansal A, Hall S, Puli S, Mathur S, Rastogi A. A feasibility trial of narrow band imaging endoscopy in patients with gastroesophageal reflux disease. Gastroenterology. 2007 Aug;133(2):454-64; quiz 674. doi: 10.1053/j.gastro.2007.06.006. Epub 2007 Jun 8.
Kumagai Y, Toi M, Inoue H. Dynamism of tumour vasculature in the early phase of cancer progression: outcomes from oesophageal cancer research. Lancet Oncol. 2002 Oct;3(10):604-10. doi: 10.1016/s1470-2045(02)00874-4.
Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.
Neumann H, Fujishiro M, Wilcox CM, Monkemuller K. Present and future perspectives of virtual chromoendoscopy with i-scan and optical enhancement technology. Dig Endosc. 2014 Jan;26 Suppl 1:43-51. doi: 10.1111/den.12190. Epub 2013 Oct 23.
Gomes CA Jr, Loucao TS, Carpi G, Catapani WR. A study on the diagnosis of minimal endoscopic lesions in nonerosive reflux esophagitis using computed virtual chromoendoscopy (FICE). Arq Gastroenterol. 2011 Jul-Sep;48(3):167-70. doi: 10.1590/s0004-28032011000300002.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
January 11, 2016
Record last verified: 2016-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: