Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes

NCT02575287 | Completed DMC

• 1 other identifier: I-JUN-17-2015
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Erosive Reflux Disease; GERD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

NERD group

(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

Device: Optical Enhancement; Device: Optical Enhancement with optical magnification; Device: Optical magnification without Optical enhancement

Control group

(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

Device: Optical Enhancement; Device: Optical Enhancement with optical magnification; Device: Optical magnification without Optical enhancement

Interventions

Optical Enhancement DEVICE

A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement (Pentax Video Processor EPK-i7010; HOYA Co. Tokyo, Japan)

Also known as: OE system

Control group; NERD group

Optical Enhancement with optical magnification DEVICE

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)

Also known as: OE sytem with optical magnification

Control group; NERD group

Optical magnification without Optical enhancement DEVICE

A endoscopic visualization of the mucosa using optical magnification without the use of the pre-processor filter called Optical enhancement

Also known as: Optical magnification without OE sytem

Control group; NERD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Above 18 years old patients
• Who agree to participate in the study
• Patients with reflux symptoms (heartburn and regurgitation), with8 or more points at the GERD questionnaire and no evidence of ulcerative esophagitis, esophageal strictures, Barrett's esophagus or any erosive sign according to Los Angeles classification (Grade A to D) in the upper endoscopy using white light nor I-Scan™

You may not qualify if:

• Patients with ulcerative esophagitis, esophageal strictures, Barrett's esophagus or any erosive sign according to Los Angeles classification (Grade A to D)
• Patients with medical history of any kind of esophagitis (including actinic, caustic or eosinophilic), achalasia.
• Esophageal varices
• Patients with evidence of cancer or mass lesion in the esophagus
• Protons bump inhibitor consumption for at least 3 weeks before endoscopy
• Inability to discontinue non steroidal anti-inflammatory drugs or aspirin prior to the study
• Severe uncontrolled coagulopathy
• Gastric lesions (ulcer, polyp, cancer), severe gastroparesis
• Prior history of esophageal or gastric surgery.
• Pregnancy and lactation

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases, Omnihospital

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (12)

• 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.

  PMID: 16928254 BACKGROUND

• 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.

  PMID: 21725507 BACKGROUND

• 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.

  PMID: 16181384 BACKGROUND

• 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.

  PMID: 22741109 BACKGROUND

• 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.

  PMID: 25273118 BACKGROUND

• 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.

  PMID: 25496815 BACKGROUND

• 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.

  PMID: 15082609 BACKGROUND

• 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.

  PMID: 17681166 BACKGROUND

• 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.

  PMID: 12372722 BACKGROUND

• 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.

  PMID: 10403727 BACKGROUND

• 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.

  PMID: 24373000 BACKGROUND

• 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.

  PMID: 21952699 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

histological biopsies from esophagus

MeSH Terms

Conditions

Non-Erosive Reflux Disease; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Carlos A Robles-Medranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: October 14, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

EC (1)