Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Ear, Nose, and Throat Diseases

Pain

Gastroesophageal Reflux

Abdominal Pain

Dyspepsia

Heartburn

Barrett Esophagus

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Precancerous Conditions

Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.

Prateek Sharma, MD

The purpose of this study is to evaluate the demographics, patients symptoms, and findings during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy suite, will be asked to fill out questionnaires pertaining to their symptoms and indications for the procedure. This will be done before their procedure during the interview period preceding endoscopy. The patient's answers to this questionnaire will aid us in determining the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms and to also determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses.

Barrett's esophagus is a pre-malignant condition associated with adenocarcinoma of the lower esophagus, and is found in 10-15% of patients with Gastroesophageal Reflux Disease (GERD). In prospective studies of patients undergoing endoscopy for reflux symptoms, the prevalence of long segments of Barrett's Esophagus (3cm or greater) is reported to be 3% and that of short segment Barrett's Esophagus (less than 3cm), to be approximately 7-8%. Early diagnosis with surveillance is considered the optimal approach in patients with Barrett's, given the poor survival of advanced adenocarcinoma of the esophagus. However, classic symptoms of GERD may be diminished in some patients with Barrett's esophagus, possibly leading to a lower incidence of endoscopy with early diagnosis.

Extraesophageal manifestations of GERD include hoarseness, wheezing, and globus sensation. Dyspepsia is defined as pain or discomfort centered in the upper abdomen. Some reports have quantified the incidence of dyspepsia as occurring in up to 40% of adults over a six-month period. The differential diagnosis of dyspepsia includes gastric or duodenal ulcer, gastroesophageal reflux disease, gastric cancer, and non-ulcer dyspepsia. The incidence of peptic ulcer disease appears to be decreasing in our population, largely due to the lower prevalence of Helicobacter pylori infection among the population. Thus, esophageal lesions are responsible for an increasing number of dyspeptic patients.

Controversies exist as to the proper management of patients presenting with dyspepsia. Empiric acid-suppression therapy is often the first step in the management of dyspeptic patients. Many physicians have adopted a test-and-treat strategy for Helicobacter pylori infection. Finally, upper endoscopy may be performed. This test is considered the gold standard for the diagnosis of esophageal and gastroduodenal lesions. The initial evaluation of dyspeptic patients may be modified by other factors in their presentation, i.e. age greater than 50 or the presence of alarm symptoms (weight loss, dysphagia, evidence of gastrointestinal bleeding, anemia, or previous gastric surgery).

A distinction between the various causes of dyspepsia is important to establish in view of the significant differences in treatment strategies. Several previously reported studies have established a correlation between dyspepsia, with or without peptic ulcer disease, and erosive esophagitis. These studies were limited by a high degree of patient selection and narrow patient populations. Although the prevalence of erosive esophagitis and Barrett's Esophagus has been reported in patients with typical GERD symptoms, i.e. heartburn and regurgitation, the exact prevalence in patients with atypical symptoms of GERD (cough, asthma, wheezing, dysphagia), abdominal pain and dyspepsia is not readily known, especially in a VA population. Given that these esophageal diseases affect mainly older Caucasian males, studying the prevalence of these diseases in a VA population would be of extreme significance and importance.

Demographics and Findings of Upper Endoscopy Patients

A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms

Kansas City Veteran Affairs Medical Center

Midwest Biomedical Research Foundation

Principal Investigator

Mouth and Tooth Diseases

Head and Neck Neoplasms

Xerostomia

Mucositis

Oropharyngeal Neoplasms

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Dissolving tablet taken by mouth (60 mg tablet), once a day. Take dose first thing in morning on empty stomach, then nothing but water for 30-45 minutes afterwards.

David I. Rosenthal, MD, MA, BA

The goal of this clinical research study is to learn if radiation-induced xerostomia \[RIX\] (dry mouth) causes, or worsens the effects of, acid reflux (heartburn and heartburn-like symptoms) in head and neck cancer (HNC) patients receiving radiation therapy.

Objectives:

Primary Objective:

Determine if radiation induced xerostomia (RIX) increases the frequency or duration of acid-reflux when re-measured approximately 6-12 weeks after RT (measured by # episodes, their duration, and Reflux Area Index (RAI). Reflux Area (RA) is the sum of the area under the curve for all episodes of pH\<4 recorded during the study in units of Ph\*minutes. The Reflux area index (RAI) is the RA corrected for the duration of the study (RA x 100/study duration).

Secondary Objectives:

1. To demonstrate that patients undergoing RT for OPC have reflux into the irradiated field that is anticipated to exacerbate mucositis symptoms
2. Correlate RAI and # episodes of acid reflux with salivary flow before and after RT to determine if radiation induced hyposalivation is associated with more reflux events and symptoms.
3. For patients with no pre-RT pathologic acid reflux, determine if RIX leads to conversion to acid-positive reflux measured approximately 6-12 weeks after RT.
4. Correlate office indirect laryngoscopy findings (posterior commissure thickening, cobble-stoning, granulomas, and arytenoids erythema or edema) suggestive of acid reflux in OPC patients with pH-probe findings as was done in larynx cancer (Lewin et al)
5. Compare findings from the patient reported outcome (PRO) instruments used

The Study Drug:

Dexlansoprazole is designed to block the production of excess stomach acid that is the cause of acid reflux disease.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 groups, based on the results of your screening tests.

If you are assigned to Group 1, you will not receive any study drug, but you will complete the study visits and radiation therapy, as described below.

If you are assigned to Group 2, you will receive Dexlansoprazole.

Study Drug Administration:

Dexlansoprazole is an dissolving tablet that is taken by mouth. It dissolves on the tongue. It should not be swallowed whole with water like a regular pill. You will take 1 tablet, once daily. The study drug should be taken first thing in the morning on an empty stomach, and then you should not eat or drink anything but water for 30-45 minutes after taking the study drug.

Study Visits:

Before you have the scheduled radiation therapy, you will have study visits. At these visits, the following tests and procedures will be performed:

* You will have a pH-probe test performed.
* You will complete the PRO questionnaires.
* You will have a whole mouth salivary flow (WMSF) test. To perform this test, you will chew a piece of non-flavored gum, and spit into a cup for after about 5 minutes. The amount saliva will be weighed and recorded to compare it the amount recorded after radiation therapy.

Radiation Therapy:

After you have completed the study visits, you will have the scheduled radiation therapy. You will be asked to sign a separate consent form for this.

Length of Study:

You will remain on study from the beginning of radiation therapy until the 6-12 week follow up visit is completed. After your participation on this study is over, you should speak with your primary doctor about long term treatment. If your acid reflux disease gets worse while on study, you will be recommended for a gastrointestinal (GI) evaluation and treatment. If you experience intolerable side effects, you will be taken off study.

Follow-Up Visits:

About 6-12 weeks after you have completed radiation therapy, you will have a follow up visit. At this visit, the following tests and procedures will be performed:

* You will have a pH-probe test performed.
* You will complete the PRO questionnaires.

This is an investigational study. Dexlansoprazole is FDA approved and commercially available for the treatment of acid reflux disease.

Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.

Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

Evaluation and Treatment of Reflux Disease in Patients With Head and Neck Cancer Undergoing Radiation Therapy That Causes Significant Mucositis in the Reflux Field and Xerostomia

TAP Pharmaceutical Products Inc.

M.D. Anderson Cancer Center

Rare Diseases

Esophageal Neoplasms

Esophagitis

Esophagitis, Peptic

Gastroenteritis

Peptic Ulcer

Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Diseases

Esophageal Cancer

Patients who have GERD will be recruited for this study.

Patients will use a decision aid administered on a computer.

Decision Aid

Chin Hur, MD, MPH

Chin Hur

The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on \~100 patients who have GERD to assess effectiveness.

Decision Aid for Gastroesophageal Reflux Disease Management

Personalized Decision Aid for the Management of Gastroesophageal Reflux Disease

Patients will be surveyed after using the intervention to determine if they felt it was useful and whether they would recommend it to others.

The Patient Satisfaction with Decision Scale will be adapted for this study. This is a six-item scale has been shown to be reliable and valid.

Patient intervention choice will be solicited both before and after the decision aid.

Massachusetts General Hospital

All subjects will receive transnasal endoscopy (EG Scan II) followed by standard endoscopy.

All subjects will receive EG Scan II (transnasal endoscopy) followed by standard endoscopy.

EG Scan II (transnasal endoscopy)

Standard Endoscopy

Prasad G Iyer, MD

The purpose of this study was to evaluate whether a disposable nasal endoscope called "E.G. Scan II" will visualize the esophagus as well as the standard test, sedated endoscopy.

All subjects underwent two procedures: the E.G.Scan II followed by standard endoscopy in a tandem design. The E.G. Scan II is a transnasal endoscope system to capture and transmit images of the esophagus. Captured images can be reviewed via the E.G. View for diagnosis of diseases related to the esophagus. Generally, the commercial esophagoscope system has reusable probes, but E.G. Scan™ II has a single use probe because reusable probes have the risk of infection and pollution.

Prior to the E.G.Scan, subjects received a standard prep for the procedure. The two procedures were performed by two different experienced endoscopists who were blinded to the indication of the procedure. At both procedures a note was made of any abnormality of the esophagus. Every subject with an endoscopic diagnosis of Barrett's Esophagus had clinical biopsies taken to confirm diagnosis. Subject tolerability was measured with a 10-point visual analog scale (VAS) where 0 represented the "worst experience" and 10 the "best experience."

Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy

On the 10-point VAS, 0 represented the "worst experience" and 10 the "best experience."

Subjects were asked the following question: "Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future?" Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test.

IntroMedic Co., Ltd.

Mayo Clinic

Associate Professor of Medicine

Presenting adverse events per per intervention was not possible, as most patients were sedated prior to the procedures and only a few were not sedated. Therefore the adverse events were per patient population (study arm).

Subjects With Barrett's Esophagus

Subjects With Reflux and/or Heartburn

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Prasad G. Iyer

EG II Scan

Median Tolerability Score on 10-point Visual Analog Scale (VAS)

Nasal Camera Test

Oral Camera Test

Either Test

Two subjects on the reflux and/or heartburn arm didn't answer this question.

Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy

EG Scan II (Day 1)

Standard Endoscopy (Day 2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Demographics and Findings of Upper Endoscopy Patients	NCT00576992	Barrett Esophag... Gastroesophagea...		18 Years -	Midwest Veterans' Biomedical Research Foundation
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy	NCT00928161	Head and Neck C... Oropharyngeal C... Gastroesophagea...	Dexlansoprazole	18 Years -	M.D. Anderson Cancer Center
Decision Aid for Gastroesophageal Reflux Disease Management	NCT01641887	Gastroesophagea... Esophageal Canc... Barrett's Esoph...	Decision Aid	18 Years -	Massachusetts General Hospital
Decision Aid for Gastroesophageal Reflux Disease Management	NCT01641887	Gastroesophagea... Esophageal Canc... Barrett's Esoph...	Decision Aid	18 Years -	Massachusetts General Hospital
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy	NCT02066233	Barrett's Esoph...	EG Scan II (tra... Standard Endosc...	18 Years -	Mayo Clinic
Prospective Study to Compare the Efficacy of E.G.Scan to Detect Barrett's Esophagus Compared With Standard Endoscopy	NCT02066233	Barrett's Esoph...	EG Scan II (tra... Standard Endosc...	18 Years -	Mayo Clinic
Demographics and Findings of Upper Endoscopy Patients	NCT00576992	Barrett Esophag... Gastroesophagea...		18 Years -	Midwest Veterans' Biomedical Research Foundation
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy	NCT00928161	Head and Neck C... Oropharyngeal C... Gastroesophagea...	Dexlansoprazole	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for heartburn

Every month we try and update this database with for heartburn 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.

Spots Global Cancer Trial Database for heartburn

Every month we try and update this database with for heartburn 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 heartburn 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.