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 The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth.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 After MI measurements are obtained, the balloon will be deflated and withdrawn.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

Rare Diseases

Ulcer

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Proton Pump Inhibitors

Yu-Xiao Yang, MD, MSCE

Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the development of a type of esophageal cancer. Recently, some studies suggested that taking these medications on a long-term basis may affect the bone. Therefore, it is important to learn whether these medications may lead to accelerated bone loss so that effective preventive measures can be developed for patients who require these medications for acid-related conditions. Several studies reported that patients receiving PPIs for many years may have increased risk of hip fractures. However, it is unclear whether this is because the PPIs cause reduced bone density or whether the increased risk of fractures has nothing to do with PPIs and is because patients who require PPIs have other illnesses that cause the increased fractures. The purpose of the study is to learn how bone structure and bone mass change after long-term PPI use.

Proton pump inhibitors (PPIs) are among the most widely used medications. It is becoming increasingly common for patients to take these potent acid suppressants on a long-term and continuous basis for erosive esophagitis, Barrett's esophagus and protection against nonsteroidal anti-inflammatory drug-related gastropathy. PPI therapy leads to elevated serum gastrin levels and may impair the absorption of calcium and food-bound vitamin B12. PPI-induced hypergastrinemia has a direct trophic effect on the parathyroid glands, leading to parathyroid hyperplasia, increased parathyroid hormone secretion and bone loss. Furthermore, both calcium malabsorption and vitamin B12 deficiency are associated with reduced bone mineral density (BMD) and increased osteoporotic fracture risk. Consistent with these data, recent studies revealed a positive association between PPI therapy and the risk of osteoporotic fractures. Peripheral quantitative computed tomography (pQCT) can provide a three-dimensional structural analysis of trabecular and cortical volumetric BMD (vBMD) and dimensions. These data are imperative for a valid assessment of the effect of chronic PPI therapy on bone strength. The investigators hypothesize that PPI therapy leads to decreased cortical and trabecular vBMD, cortical dimensions and bone strength.

To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use

Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood

monitor change in PTH levels because long-term PPI therapy may have an affect on parathyroid glands, increasing parathyroid hormone (PTH) secretion.

low B12 levels have been associated with reduced bone mineral density (BMD) as well osteoporotic fracture risk

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institutes of Health (NIH)

University of Pennsylvania

Gastrointestinal Agents

Esomeprazole

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.

The patients in this group were advised to take PPI QD continuously for 48 weeks.

Esomeprazole 40mg

SUNG-SHUO KAO, Bachelor

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial

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
To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use	NCT01306799	Barrett's Esoph... Erosive Esophag... Gastroesophagea...		40 Years - 75 Years	University of Pennsylvania
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.	NCT04329000	Barrett Esophag... Proton Pump Inh... Symptom Reflux	Esomeprazole 40... Esomeprazole	20 Years - 80 Years	Kaohsiung Veterans General Hospital.

Spots Global Cancer Trial Database for erosive esophagitis