Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Omeprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)

treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Argon Plasma Coagulation 90W power

Argon Plasma Coagulation 60W power

Omeprazole 120 mg

Omeprazole 40 mg

Background and study aims. To evaluate the impact of power setting and proton pump inhibitor (PPI) dose on the efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD).

Patients and methods. Investigator initiated, single-center, parallel-group randomized controlled trial (RCT) conducted in a tertiary referral center in Poland. Consecutive patients with BE and LGD were randomly assigned to APC with power set at 90 Watt (90W) or 60 Watt (60W) followed by 120 mg or 40 mg omeprazole for six weeks. The primary outcome of the study was the rate of complete (endoscopic and histologic) ablation of BE at six weeks. Secondary outcomes included safety and long-term efficacy (at two years and at the end of a long-term follow-up of over 4 years.

Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.

Patients were blinded to the power settings used for APC, but they knew the PPI dose they received. The endoscopist performing APC ablation was blinded to participant allocation and APC power setting (the power was set up by an assistant who knew the group allocation and the power display remained covered during the entire procedure). The endoscopist and pathologist involved in efficacy assessment were blinded to participant allocation.

Argon Plasma Coagulation for Barrett's Esophagus

Argon Plasma Coagulation for Barrett's Esophagus With Low Grade Dysplasia: A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose

Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands

Centre of Postgraduate Medical Education

Maria Sklodowska-Curie National Research Institute of Oncology

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Metaplasia

Hyperplasia

Esophageal Cancer

Anti-Infective Agents

Antineoplastic Agents

Micronutrients

Vitamins

Acetic Acid

Retinol acetate

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Retinol

Acetic acid is prepared at a concentration of 2.5%, after initial cleaning is done, it will be applied with a 7 French spray catheter, starting the proximal application performing a uniform application on the area of intestinal metaplasia an then will be timed for mucous visualization in search of areas of loss of acetowhitening, in case of finding such area will be registered the time in which there was loss of acetowhitening, the distance at which it is located from the upper dental arch in addition to the esophageal face on which the area is located, subsequently evaluation of the glandular pattern is performed only by classifying as normal (glands evenly distributed with normal or abnormal crypt density (compact crypts with increased density; focal irregularity or disorganized crypts; absence of a cryptic pattern), once this evaluation has been carried out, biopsies are directed to these areas to be sent to the pathology service.

Take random biopsies by quadrants every 2 centimeters biopsy of the intestinal metaplasia areas 1cm above the esophagogastric junction begins, taking tissue every 2cm from the 4 quadrants, separating the biopsies in different bottles based on the length in which they were taken, to later be sent to the pathology service.

Acetic acid is prepared at a concentration of 2.5% in a 20ml syringe, it will be applied with a 7 french spray catheter compatible with a working channel 2.8mm onwards, starting the proximal application When distally performing a uniform application on the area of intestinal metaplasia and the timed time for mucous visualization in search of areas of loss of acetowhitening begins, in case of finding such area will be registered the time in which there was loss of acetowhitening, the distance at which it is located from the upper dental arch in addition to the face on which the area is located, subsequently evaluation of the glandular pattern is performed only by classifying as normal or abnormal, once this evaluation has been carried out, biopsies are directed to these areas to be sent to the pathology service.

Acetic acid chromoendoscopy

Take random biopsies by quadrants every 2 centimeters. Biopsy of the intestinal metaplasia areas 1cm above the esophagogastric junction will be initiated, taking tissue every 2cm from the four quadrants, separating the biopsies in different bottles based on the length in which they were taken, to later be sent to the pathology service.

Seattle protocol

Oscar V Hernández Mondragón, MD

Raul Alberto Gutiérrez Aguilar, Fellow

Oscar V Hernandez Mondragon, MD

Barrett's esophagus is a complication of chronic gastroesophageal reflux disease that occurs in up to 10% to 15% of patients with this pathology. Well-defined risk factors have been established and are important because they are considered a precancerous lesion (intestinal metaplasia). The conventional diagnostic methods are ineffective in reliably detecting potentially treatable lesions. Investigators propose the use of vital chromoendoscopy with acetic acid using the simplified classification of Portsmouth looking for areas with loss of acetowhitening and taking targeted biopsies to increase the detection of esophageal neoplastic lesions.

Barrett's esophagus is a complication of chronic gastroesophageal reflux disease that occurs in up to 10 to 15% of patients with this disease, well-defined risk factors have been established and are important because they are considered a precancerous condition (metaplasia intestinal). Chromoendoscopy is postulated as an effective way for the detection of esophageal precancerous lesions, early detection and timely treatment with chromoendoscopy with acetic acid being a seemingly reliable alternative, so the investigators will use with the simplified classification of Portsmouth looking for areas with loss of acetowhitening and targeted biopsy to increase the detection of esophageal neoplastic lesions, our main objective being to compare the diagnostic effectiveness of directed biopsies of dysplastic lesions with acetic acid in patients with Barrett's esophagus compared to taking non-directed protocolized biopsies.

A clinical trial will be carried out, including all those patients older than 18 years who go to perform a superior endoscopy with diagnosis of Barrett's esophagus where patients will be up and B Seattle protocol group(four quadrant biopsy every 2 centimeters starting 1 centimeter from above the esophagogastric junction), then proton pump inhibitor washout and crossover allocation with the opposite corresponding manoeuver. Histopathological results of both groups will be compared.

Demographic data of the participants will be collected and the evaluated areas of Barrett's esophagus with each method will be recorded in a data collection sheet detailing in a specific way the number of biopsies taken, specifying if there was loss of acetowhitening and alterations in the mucous pattern and in the case of the opposite arm, the total number of biopsies taken based on the Seattle protocol, said data will be condensed into a database for subsequent statistical analysis and publication of results.

A clinical trial will be carried out, including all those patients older than 18 years who go to perform a superior endoscopy with diagnosis of Barrett's esophagus where patients will be randomized into two groups, one of acetic acid and the other of the Seattle protocol as a method Initially and subsequently, a second endoscopy will be performed with the opposite method and the histopathological results of both groups will be compared.

Participant will be initially allocated in either group without knowing its initial manoeuver

Acetic Acid for the Detection of Esophageal Neoplasms

Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus

First the investigators will detect the incidence of dysplasia in Barrett esophagus in patients with acetic acid chromoendoscopy, using the Vienna Classification system by the pathologist.

The second maneuver consist on taking non directed biopsies by the Seattle protocol in the same patient. And the incidence of dysplasia on biopsies will be looked for using Vienna Classification system again.

Coordinación de Investigación en Salud, Mexico

Ear, Nose, and Throat Diseases

Adenocarcinoma

Gastroesophageal Reflux

Esophagitis

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastroenteritis

Individuals who underwent endoscopy and were found to only have one of the following:

* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Individuals who underwent endoscopy and were found to only have one of the following:

* Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length
* Esophageal adenocarcinoma of any stage
* Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following:

* Craniocaudal maximal extension of 3 cm or more
* Low-grade dysplasia at most, independently of Barrett's segment length

Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.

A panel of circulating microRNA, whose expression level is tested in cell-free derived samples.

EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Ajay Goel, PhD

This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses.

Esophageal adenocarcinoma (EAC) is a significant global health concern, ranking second in lethality (after pancreatic cancer). Despite being potentially preventable, it remains a leading cause of cancer-related deaths. Traditional screening methods have relied on an endoscopy-first approach to screen for the precursor of EAC, which is Barrett's esophagus (BE). After BE detection, BE is then regularly surveiled to monitor the development of dysplasia, which can be treated to prevent malignant transformation. An endoscopy-first approach is sensitive BE and, therefore, it lowers the risk of developing EAC but it also faces challenges such as invasiveness, cost, and patient compliance.

Non-invasive tests are more appealing to patients than invasive tests and can increase participation rates. Biomarker studies have shown promise, but existing tests lack sensitivity for early-stage EAC and, most importantly, to its precursor lesion BE. This is likely because they over-sampled analytes that are primarily expressed at the EAC end of the spectrum, but not in BE yet during the BE to EAC sequence.

This study proposes developing an innovative liquid biopsy test tailored for EAC and BE to address this. An ideal screening test should be minimally invasive, highly sensitive, and cost-effective. This test would optimize patient compliance and resource allocation by detecting both conditions from a single blood draw. More specifically, circulating microRNA (miRNA) analysis shows promise: tests based on cell-free microRNA (cf-miRNA) have demonstrated high sensitivity.

This study will develop a non-invasive blood test for BE and EAC in four phases:

1. In silico genome-wide profiling of tissue miRNA to select the best candidates for biomarker panels.
2. Prioritization of the biomarkers that are differentially expressed across the entire continuum of BE to EAC sequence, compared to the normal mucosa
3. Transition of these biomarkers to a liquid biopsy assay, confirming their detectability in blood as well as their differential expression in cases compared to controls
4. Utilizing machine learning to identify the most promising candidates and train algorithms for detecting EAC and BE, based on results from quantitative polymerase chain reaction (qPCR) analysis.
5. Independently validating these signatures using diverse cohorts to ensure broad applicability and compare the effectiveness of the blood assay to standard care through retrospective and prospective studies.

This study aims to develop a highly sensitive, specific, and cost-effective liquid biopsy for early detection of BE and EAC. Success could transform clinical practice by preventing EAC through early detection of pre-malignant lesions. Innovations include incorporating pre-malignant lesions into screening. This approach could potentially reduce EAC mortality and incidence and pave the way for new clinical trials.

A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma

A Liquid Biopsy to Screen for Barrett's Esophagus, Dysplasia, and Esophageal Adenocarcinoma: the EMERALD Multi-center Study.

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Argon Plasma Coagulation for Barrett's Esophagus	NCT04154748	Barretts Esopha...	Argon Plasma Co... Argon Plasma Co... Omeprazole 120 ... Omeprazole 40 m...	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology
Acetic Acid for the Detection of Esophageal Neoplasms	NCT04054713	Barretts Esopha... Dysplasia Intestinal Meta...	Acetic acid chr... Seattle protoco...	18 Years -	Coordinación de Investigación en Salud, Mexico
A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma	NCT06381583	Esophagus Cance... Esophageal Canc... Esophageal Canc... Esophageal Neop... Esophagus Adeno... Esophagus, Barr... Barrett Esophag... Barrett Adenoca... Barrett Epithel... Barretts Esopha... Barrett's Esoph... Barretts Esopha... Barretts Esopha... Barrett Esophag... Barrett's Esoph... Barrett's Esoph... Gastroesophagea... Reflux Disease Esophageal Aden... Esophageal Dysp... Esophageal Neop...	EMERALD (Esopha...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for barretts esophagus with low grade dysplasia