Digestive System Diseases

All Conditions

Neoplasms

Ear, Nose, and Throat Diseases

Gastroesophageal Reflux

Esophagitis

Barrett Esophagus

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Gastroenteritis

Precancerous Conditions

Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.

Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.

Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.

Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.

Confocal endomicroscopy

Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.

Endoscopic biopsies

MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.

Mucosal impedance (MI)

Pritesh R Mutha, MD,MPH

Pritesh R Pritesh, MD,MPH

Tilak Shah, MD

Mitchell Schubert, MD

Alvin Zfass, MD

Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Investigator in the lab performing Ussing's chamber analysis will be blinded to the diagnosis of the patient

Hunter Holmes McGuire VA Medical Center

McGuire Research Institute

Symptoms and General Pathology

Esophagitis, Peptic

Peptic Ulcer

Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

Lansoprazole oral tablets 30 mg

The trial would to try to establish:

* The best post-operative PPI prescription protocol after Sleeve Gastrectomy
* The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)
* The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ

45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)

GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

PPI Therapy Impact on GERD After Sleeve Gastrectomy

Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study

Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A \<8 no GERD, score A \>8 and B \> 3 GERD worsening normal life)

Mucosal damage evaluation and stratified accordingly

University of Roma La Sapienza

MD PhD

Nutritional and Metabolic Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Stomach Neoplasms

Syndrome

Esophageal Neoplasms

Obesity

Irritable Bowel Syndrome

Crohn Disease

Colonic Polyps

Colitis

Colitis, Ulcerative

Gallstones

Cholelithiasis

Cholecystolithiasis

Celiac Disease

Polyps

Eosinophilic Esophagitis

Metaplasia

Gastritis

Colitis, Microscopic

Stomach Ulcer

Duodenal Ulcer

Colitis, Lymphocytic

Inflammatory Bowel Diseases

Colonic Diseases

Colonic Diseases, Functional

Eosinophilia

Leukocyte Disorders

Hematologic Diseases

Hypersensitivity

Hypersensitivity, Immediate

Biliary Tract Diseases

Gallbladder Diseases

Calculi

Pathological Conditions, Anatomical

Malabsorption Syndromes

Metabolic Diseases

Stomach Cancer

Esophageal Cancer

Eosinophilic Gastroenteritis

Hematinics

Herbal and Botanical

Liver Extracts

Cola

Participants with Eosinophilic esophagitis

Participants with Gastroesophageal Reflux Disease (GERD).

Participants with intestinal metaplasia (risk factor for esophageal cancer).

Participants with Lymphocytic/Microscopic Colitis.

Momchilo Vuyisich

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

This is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. Molecular and metadata will be collected from a large study population at multiple time points. Machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.

Systems Biology of Gastrointestinal and Related Diseases

Identification of biomarkers that indicate gastrointestinal diseases.

Identification of microbial species that indicate gastrointestinal disease.

Prediction of the efficacy of a biologic medication against IBD based on molecular data and metadata.

Development of a molecular test for C. difficile infection (CDI)

Quantification of changes observed in the microbiome post colonoscopy.

Viome

Atrophy

Neuroendocrine Tumors

Gastritis, Atrophic

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Patients with an established diagnosis of ulcerative colitis or Crohn's Disease who require either a flexible sigmoidoscopy or colonoscopy as part of routine care (e.g. surveillance or staging disease activity)

Patients with symptoms of gastro-oesophageal reflux disease requiring a gastroscopy as part of routine clinical care.

Patients with known or suspected atrophic gastritis that require a gastroscopy to either confirm the diagnosis or surveillance for pre-cancerous changes.

Patients with an established history of gastric neuroendocrine tumours requiring surveillance

Mehul Patel, MBBS, BSc

Lee Meng Choong

Mehul Patel, MBBS

Bu'Hussain Hayee, PhD, MBBS,

This study evaluates a range of endoscopic image enhancement techniques for assessing conditions involving the gastrointestinal tract.

This study aims to determine:

(i) the accuracy of different techniques to diagnose or grade severity of several gastrointestinal conditions

(ii) if image-enhancement techniques could potentially replace investigations currently used in daily practice (e.g. biopsy) with a view to reduce costs and shorten the interval to initiate treatment

Endoscopic procedures are performed on a daily basis to visualise the gastrointestinal tract for diagnosis and intervention. The demand for procedures is growing, consequently increasing the number of additional investigations; for example, biopsies. Image enhancement techniques can be performed during procedures either digitally or through the use of dye. These techniques alter the qualities of the image e.g. colour, contrast and magnification. We believe these techniques have several potential benefits: (i) improve diagnostic accuracy (ii) filter appropriate selection of additional investigations to maximise diagnostic yield (iii) the potential to replace existing investigations which are costly and intricate.

Participants included in the study will have an endoscopic procedure as indicated for routine clinical care. On the day of the procedure (or before), a baseline assessment will be performed - symptom questionnaires, medical history and recording any relevant investigation results performed as part of routine care. Participants will have the endoscopic procedure as normal, with additional images and video obtained using different image enhancement techniques. Select patients will have follow-up for up to one year to determine relapse. The image enhancement technique findings will be compared to the gold standard investigation currently available as part of routine care for the condition of interest.

The study will look at a range of different image enhancement techniques: dye chromoendoscopy, blue laser imaging (BLI), linked colour imaging (LCI), narrow band imaging (NBI), image magnification and endocytoscopy. This will involve a range of gastrointestinal conditions.

Ethics Approval: favourable opinion was provided by the East Midlands - Derby research and ethics committee, reference: 19/EM/0167.

Image-Enhanced Endoscopy in the Gastrointestinal Tract

A Series of Prospective Observational Studies Investigating the Clinical Utility of Image-enhanced Endoscopy in the Gastrointestinal (GI) Tract

Identify specific features on NBI,BLI, LCI, magnification and endocytoscopy to accurately diagnose / grade severity of a range of conditions when compared to the gold standard diagnostic investigation e.g. biopsy, pH impedance testing

Relapse as defined by the requirement for treatment escalation, surgery, hospital admission; biochemical evidence of relapse (faecal calprotectin) or worsening inflammation on repeat endoscopy.

median duration (minutes) as defined as the time interval between insertion and completed withdrawal of the endoscope

King's College Hospital NHS Trust

No intervention

Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies.

Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population.

Study design: Cross-sectional population-based survey.

Study population: Dutch citizens aged 18-75 years.

Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.

Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study.

Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.

Gastroesophageal Reflux Disease in the Dutch Population

Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey

The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.

The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age\>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree).

Participants with GERD will be asked whether they discussed their symptoms with their GP, whether they have been referred to a gastroenterologist or internist and what their reasons were for seeking help or not seeking help (answer options were based on qualitative research).

Participants will be asked to indicate whether they used prescribed Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.

Participants will be asked to indicate whether they used over-the-counter Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.

The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The beliefs module measures whether participants think esophageal cancer can be treated, can be cured, is a death sentence, can benefit from early detection and whether they would wish to know about de diagnosis on a 4 point Likerts scale (strongly disagree - strongly agree).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)	NCT03228407	Gastro Esophage... Barrett Esophag... Erosive Esophag...	Confocal endomi... Endoscopic biop... Mucosal impedan...	18 Years -	McGuire Research Institute
PPI Therapy Impact on GERD After Sleeve Gastrectomy	NCT04400136	Gastro Esophage... Barrett Esophag... Bariatric Surge...	Lansoprazole or...	18 Years - 65 Years	University of Roma La Sapienza
Systems Biology of Gastrointestinal and Related Diseases	NCT05579444	Ulcerative Coli... Crohn Disease Obesity Colon Polyp Eosinophilic Es... GERD Gastro Esophage... Barrett Esophag... Esophageal Canc... Gastritis Gastric Ulcer Duodenal Ulcer Intestinal Meta... Gastric Cancer Lymphocytic Col... Microscopic Col... Celiac Sprue IBS Irritable Bowel... SIBO NAFLD Gallstone Disea...		18 Years -	Viome
Image-Enhanced Endoscopy in the Gastrointestinal Tract	NCT04085211	Gastro-Intestin... Inflammatory Bo... Gastro Esophage... Atrophic Gastri... Neuroendocrine ...		18 Years - 90 Years	King's College Hospital NHS Trust
Gastroesophageal Reflux Disease in the Dutch Population	NCT05689918	Gastro Esophage...	No intervention	18 Years - 75 Years	Radboud University Medical Center
PPI Therapy Impact on GERD After Sleeve Gastrectomy	NCT04400136	Gastro Esophage... Barrett Esophag... Bariatric Surge...	Lansoprazole or...	18 Years - 65 Years	University of Roma La Sapienza
Systems Biology of Gastrointestinal and Related Diseases	NCT05579444	Ulcerative Coli... Crohn Disease Obesity Colon Polyp Eosinophilic Es... GERD Gastro Esophage... Barrett Esophag... Esophageal Canc... Gastritis Gastric Ulcer Duodenal Ulcer Intestinal Meta... Gastric Cancer Lymphocytic Col... Microscopic Col... Celiac Sprue IBS Irritable Bowel... SIBO NAFLD Gallstone Disea...		18 Years -	Viome

Spots Global Cancer Trial Database for gastro esophageal reflux