Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Ear, Nose, and Throat Diseases

Gastroesophageal Reflux

Barrett Esophagus

Metaplasia

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Precancerous Conditions

NBI-AFI imaging - Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source.

Autofluorescence Imaging (AFI)- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm)

Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars

Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source.Target biopsies with standard biopsy forceps will be obtained from the different visualized patterns in separate jars.

Autofluorescence Imaging- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm).In this system, normal squamous and non-dysplastic BE appears green while the dysplastic areas appear magenta/purplish. Targeted biopsies will be obtained from the areas with abnormal fluorescence.

NBI-AFI imaging

Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars.

Standard Endoscopy

Prateek Sharma, MD

Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy, novel techniques (NBI and AFI) with target biopsies will

* Detect more patients with intestinal metaplasia
* Detect more areas of high grade dysplasia
* Require fewer biopsies and a shorter time for procedure completion

Secondary Aim:

* Compare the yield of high-grade dysplasia(HGD)using NBI/AFI versus standard endoscopy with biopsy.
* Compare the number of biopsies and procedure times for NBI/AFI versus standard endoscopy with biopsy.
* Compare the inter-observer variability in classifying different mucosal and vascular patterns observed by NBI/AFI using kappa statistics.

Barrett's esophagus (BE) is the pre-malignant lesion for adenocarcinoma of the esophagus and esophagogastric junction. It is a condition in which the squamous mucosa of the distal esophagus is replaced by columnar mucosa, specifically intestinal metaplasia. The incidence of esophageal adenocarcinoma has been rapidly rising and has increased 3-6 fold over the past two decades. This has driven efforts to identify patients with the pre-malignant lesion i.e. BE. Intestinal metaplasia within the columnar lined esophagus is the epithelial type that predisposes patients to the development of adenocarcinoma; the other two epithelial types being cardiac and fundic.

Since intestinal metaplasia is now included in the definition and is the epithelial type associated with cancer, obtaining biopsies from the columnar lined distal esophagus is mandatory. The sensitivity and the positive predictive value of standard EGD for diagnosing BE has been reported as 82% and 34% respectively. This is secondary to the patchy and mosaic presence of intestinal metaplasia in the columnar distal esophagus. Endoscopic screening is advocated in patients with chronic GERD symptoms for detection of BE with random biopsies being obtained if a columnar appearing distal esophagus is visualized. Once intestinal metaplasia is detected with these random biopsies and the diagnosis of BE is confirmed, patients are subsequently enrolled in a surveillance program. Similarly, the presence of dysplasia or early adenocarcinoma within a segment of BE is patchy and focal and standard endoscopy and random biopsies may fail to detect these lesions. New endoscopic imaging techniques to improve the accuracy of endoscopic diagnosis have recently been developed, and most are currently under evaluation.

METHODS Study Overview:Patient presenting to GI lab for BE screening and surveillance Informed consent signed and patient randomized, if endoscopic BE is suspected to NBI target biopsies or standard endoscopy with biopsies as the first procedure If randomized to NBI first: patterns noted, target biopsies obtained from specific patterns Same patient returns in 3-6 weeks for 2nd procedure Standard endoscopy: 4 quadrant every 2 cms. random biopsies (i.e. standard BE surveillance) Findings of NBI and random biopsies compared after all patients complete protocol and results analyzed A process similar to the one outlined above will be used in comparing autofluorescence imaging to conventional endoscopy in patients with Barrett's mucosa.

Study Design:This study is part of a multicenter randomized controlled trial being conducted at two sites, the other one being Medical University of South Carolina. Patients will be randomized (opaque sealed envelopes generated by statistician) to undergo NBI/AFI or standard endoscopy with biopsies on day 1. The same patient will return for the alternative procedure with biopsies within 3-6 weeks of the 1st procedure and will be maintained on acid suppressive therapy during this time interval. Each patient will thus act as his/her own control. At the time of performing the 2nd procedure (either NBI/AFI target biopsies or standard endoscopy), the endoscopist will be blinded and will not be aware of the biopsy results from the 1st procedure. Every attempt will also be made to keep the endoscopists blinded to the past history of the patient i.e. non dysplastic BE, LGD, HGD etc.

Risk and benefit to the study participant:Data on newer imaging method like NBI and AFI are mostly in the form of case series. This has not led to a change in the standard of care. The early data is very encouraging but not conclusive due to lack of randomized, controlled trials. Hence, we chose a study design of randomized controlled trial of the newer modalities versus the existing conventional endoscopy. This design necessitates the performance of a repeat endoscopy. Upper endoscopy is very safe, routinely done procedure with a low risk of complications. A repeat procedure may, indeed, increase the potential for risks associated with the procedure but the magnitude is small. The added advantage of second endoscopy would be increased detection of dysplasia and adenocarcinoma resulting in potential benefit to the patients. The main reason for the performance of the current study is the limitation of conventional endoscopy with the implication that dysplasia and adenocarcinoma will be missed on the initial endoscopy. In clinical practice, this usually warrants a follow up endoscopy that is performed at 1-3 yr intervals due to time and cost constraints. For the study population of this trial, the second endoscopy has the potential for increased detection of dysplasia/early adenocarcinoma in the Barrett's segment that could lead to initiation of curative therapy.

Study Population:Patients undergoing BE screening and surveillance will be enrolled after written, informed consent. BE definition- columnar mucosa in the distal esophagus of any length with intestinal metaplasia on biopsy. The BE length will be measured from the gastroesophageal junction to the proximally displaced squamo-columnar junction. The patient demographics (age, gender and ethnicity) and the BE length will be recorded. Total time required for each procedure will be recorded - from endoscope insertion to removal.

Narrow Band Imaging: Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source (already available at both centers). The outer diameter of the endoscope is 10.8 mm similar to standard diagnostic endoscopes. No special processing or cleaning of the endoscope is required - similar to the standard Olympus GIF-100. A cap may or may not be fitted on the distal tip of the endoscope allowing the mucosa in contact with the cap to be magnified without the motility of the esophagus affecting visualization. The different patterns will be grouped into ridge/villous, circular and irregular/distorted. Target biopsies with standard biopsy forceps will be obtained from the different visualized patterns in separate jars.

Autofluorescence Imaging: Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm). The AFI scope has two different CCD (charge coupled device to detect the light waves emitted/reflected from the biological tissue - similar to the chip used in a digital camera), one for conventional and another for AFI endoscopy. There is also a rotary filter that allows blue, red or green light to be generated selectively. The video processor constructs video images (AFI images or normal optical images) based on the signals provided by CCD at the distal end of the endoscope. In this system, normal squamous and non-dysplastic BE appears green while the dysplastic areas appear magenta/purplish. Targeted biopsies will be obtained from the areas with abnormal fluorescence. Both the NBI and AFI equipment will be supplied by Olympus America Inc.

Standard Endoscopy: Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars.

Histology: All biopsy specimens will be stained with H\&E and alcian blue at pH 2.5 \& will then be reviewed by two pathologists (SM) and (DL), one at each site, who will be blinded to the NBI/AF results and patterns. Any disagreement in the histological diagnosis will be resolved by a consensus diagnosis. Dysplasia will be classified as no dysplasia, LGD, HGD and adenocarcinoma.

Data Collection:Patient demographics, order of randomization, endoscopy findings (BE length, NBI patterns, AFI patterns), procedure time, number of biopsies and histology reports will be collected and recorded by the study coordinator. All this information will be transferred into an ACCESS database

Statistical Power \& Data Analysis:For the primary outcome, to determine if NBI/AFI target biopsies can diagnose BE (intestinal metaplasia) in 90% of the patients assuming that standard endoscopy with biopsy can diagnose Barrett's in 70%, we would need 122 patients in order to detect a significant difference between the two with 80% power and a type I error rate of 5% using McNemar's test for paired dichotomous responses.

For the secondary outcome of detection of HGD will be based on number of biopsies harboring HGD. If we assume that NBI/AFI can detect areas of HGD (within the BE segment) in 90% of the biopsies from irregular/distorted patterns compared to 60% by standard endoscopy, we would need to study 59 areas/biopsies of HGD in order to detect a significant difference between the two with 80% power and a type 1 error rate of 5% using McNemar's test for paired dichotomous responses. If we enroll at least 10-12 patients with HGD with an average BE length of 5 cms, we will be able to evaluate \> 60 areas of HGD with each procedure. Each site will have to enroll approximately 30-35 BE patients (including 5-6 with HGD) each year.

McNemar's test will be used to compare paired categorical data while continuous paired data will be compared using non-parametric methods such as the Wilcoxon Sign Rank Test. A p value of \<0.05 will be considered significant.

For the initial 30 consecutive patients enrolled in the study, inter-observer variability will be studied on the mucosal and vascular patterns and autofluorescence patterns.

Novel Imaging Techniques in Barrett's Esophagus

Detection Of Intestinal Metaplasia And High Grade Dysplasia In Barrett's Esophagus Using Novel Imaging Techniques - A Randomized Controlled Trial.

Kansas City Veteran Affairs Medical Center

Medical University of South Carolina

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Midwest Biomedical Research Foundation

Professor of Medicine

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

Patients will be randomised to be examined by standard videoendoscopy (SE) then combined AFI/NBI during the esophagogastroduodenoscopy (EGD) examination at same setting.

Patients will be randomised to be examined by combined AFI/NBI then standard videoendoscopy (SE) during the EGD examination at same setting.

Jimmy BY So, MBChB

Videoendoscopy is the standard tool for examination of gastrointestinal tract. However, precancerous lesions and early gastric cancer can be easily missed by routine videoendoscopy. Autofluorescence Imaging (AFI) and Narrow band imaging (NBI) are 2 new imaging systems used in endoscopy which are recently developed. AFI based on the presence of natural tissue fluorescence on the gastrointestinal tract. By computation of the difference in the reflecting images, the system can reveal early cancers that are not detectable by standard endoscopy. NBI is a high resolution imaging using lights with narrowed wavelength range, which able to enhance the fine structure of the mucosa. Recent studies suggested combined AFI and NBI can improve the detection of early esophageal and gastric cancers.

The investigators are conducting a prospective randomized cross-over study to compare the accuracy between this combined AFI/NBI imaging with standard videoendoscopy in the detection of precancerous lesions and gastric cancer in a high risk population inSingapore. The investigators hypothesis is that this new combined imaging system improves the investigators detection of high risk lesions of stomach.

Gastric cancer remains one of the leading causes of cancer deaths worldwide. Early detection and diagnosis of gastric cancer improves the outcomes of treatment. However, most of gastric cancers detected in Singapore are late and advanced in stages.

Videoendoscopy is the standard tool for examination of gastrointestinal tract. Despite the improvement of technology, early gastric cancers can be easily missed by routine examination, because there are few morphological changes. Therefore, a functional imaging modality, that can distinguish abnormal lesion from surrounding normal mucosa may complement the current videoendoscopy.

Autofluorescence Imaging (AFI) based on the presence of natural tissue fluorescence on the gastrointestinal tract. When the mucosa was exposed by an excitation light, certain endogenous molecules (fluorophores) will emit fluorescence light of longer wavelength. The fluorescent light can be detected and spectrally analyzed. By computation of the difference in the reflecting images, the system can specify lesions, including malignancies from the adjacent mucosa, and can reveal early cancers that are not detectable by standard endoscopy.

Narrow band imaging (NBI) is another novel optical imaging technique based on high resolution imaging, which aims at enhancing the fine structure of the mucosa. In NBI, the band widths of the red, blue, green components of the excitation light are narrowed to certain wavelength ranges, which allow better contrast of the superficial mucosa and the vascular structure. NBI has a maximum zoom capacity of 115 times. Abnormal lesions are detected by the presence of abnormal mucosal and vascular patterns.

Recent studies suggested that these AFI and NBI systems can be complementary to each other. The resolution of AFI is low but it can be used as a 'red flag' technique to screen any suspicious lesions from the normal mucosa. On the other hand, NBI produces high resolution images which allows detailed examination and subsequent target biopsy of the suspicious lesions based on AFI. Preliminary reports from Japan and the Netherlands suggested this combined imaging method improves the detection of early esophageal and gastric cancers. Recently, a new endoscopy system has been developed that incorporates standard videoendoscopy system with both AFI and NBI modes. By pressing a switch, the endoscopy system can switch from normal white light to either a narrow band light or autofluorescence mode. This novel system reduces the convenience and discomfort for the patients to avoid repeated intubation. The purpose of this study is to prospectively evaluate this combined imaging modality for detection of high risk gastric lesions and early cancers by comparing it with standard videoendoscopy in a randomized fashion.

A Randomized Study Comparing Autofluorescence Imaging(AFI) Followed by Narrow Band Imaging(NBI) With Videoendoscopy for the Detection of High Risk Lesions of Stomach

A Randomized Study Comparing Endoscopic Video-Autofluorescence Imaging Followed by Narrow Band Imaging With Standard Videoendoscopy for the Detection of High Risk Lesions of Stomach

The purpose of this study is to prospectively evaluate this combined imaging modality for detection of high risk gastric lesions and early cancers by comparing it with standard videoendoscopy in a randomized fashion.

We aim to identify a method to improve our diagnosis of high risk gastric lesions in our population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Imaging Techniques in Barrett's Esophagus	NCT00576498	Barrett Esophag... Gastroesophagea...	NBI-AFI imaging Standard Endosc...	18 Years -	Midwest Veterans' Biomedical Research Foundation
Novel Imaging Techniques in Barrett's Esophagus	NCT00576498	Barrett Esophag... Gastroesophagea...	NBI-AFI imaging Standard Endosc...	18 Years -	Midwest Veterans' Biomedical Research Foundation
A Randomized Study Comparing Autofluorescence Imaging(AFI) Followed by Narrow Band Imaging(NBI) With Videoendoscopy for the Detection of High Risk Lesions of Stomach	NCT01132534	Gastric Cancer		50 Years -	National University Hospital, Singapore

Spots Global Cancer Trial Database for afi

Every month we try and update this database with for afi cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for afi

Every month we try and update this database with for afi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for afi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.