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Esophageal Diseases clinical trials

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NCT ID: NCT02998606 Terminated - Esophagus Disorder Clinical Trials

Movantik for Opioid-Related Esophageal Disorders

Start date: January 2017
Phase: Phase 2
Study type: Interventional

To date, few studies have assessed the effect of opioids on esophageal motility, mostly assessed the effect of single-dose intravenous morphine on esophageal motility. Recently a large retrospective study assessing the effect of opioids on esophageal motility found that esophageal motor dysfunction are common in chronic opioid users whether studied on opioids and off opioids. In addition, current opioid users also had significantly higher integrated relaxation pressure and manometric patterns consistent with type III achalasia. (Ratuapli 2015) Peripherally acting mu opioid receptor antagonists (PAMORA) appear to be useful to reduce the peripheral effects of mu opioid receptor agonists to delay gastrointestinal transit without affecting the centrally mediated analgesic effects. MOVANTIK™ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. MOVANTIK™ (Naloxegol) has been recently approved for opioid-induced constipation. Given orally, 25 mg daily it improves symptoms of constipation. At this dose, MOVANTIK™ (Naloxegol) is effective and safe, with a limited side effect profile and is associated with preservation of centrally mediated analgesia. This study will explore the safety and tolerability of MOVANTIK™ (Naloxegol) in this patient population. The investigational hypothesis is that MOVANTIK™ (Naloxegol) could improve opioid- induced esophageal motility disorders

NCT ID: NCT02988934 Terminated - Clinical trials for Gastroesophageal Reflux

The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry

Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach.). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus. By recording the results of all of your biopsies over many years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer. The data from your biopsies will be used to determine the best way to diagnose esophageal disease. You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of your standard clinical care, and you are between the ages of 18 and 80.

NCT ID: NCT02905669 Recruiting - Clinical trials for Esophageal Dysfunction

Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)

NormaFLIP
Start date: September 13, 2017
Phase: N/A
Study type: Interventional

Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.

NCT ID: NCT02663206 Withdrawn - Clinical trials for Esophageal Achalasia

Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders

Start date: September 2016
Phase: N/A
Study type: Interventional

To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in spastic esophageal disorders.

NCT ID: NCT02620176 Recruiting - Esophageal Diseases Clinical Trials

The Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Oesophageal Pain Hypersensitivity

Start date: December 2014
Phase: N/A
Study type: Interventional

We are evaluating the role of transcutaneous electrical vagal nerve stimulation in the prevention of oesophageal pain hypersensitivity using a validated human model in healthy volunteers.

NCT ID: NCT02569073 Withdrawn - Esophageal Diseases Clinical Trials

Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain

ICAMP
Start date: June 21, 2017
Phase: Phase 4
Study type: Interventional

In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were not adversely affected by this regiment. In fact, some cholesterol measures trended in a favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the dose and extending the duration will continue to show an improvement in symptoms as well as no adverse metabolic outcomes.

NCT ID: NCT02526095 Recruiting - Esophageal Disease Clinical Trials

The French EsoGastricTumours Data Base

FREGAT
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.

NCT ID: NCT02476513 Completed - Esophageal Diseases Clinical Trials

Clinical and Molecular Assessment of Men With High Risk for Esophageal Disorders

Start date: February 2014
Phase: N/A
Study type: Observational

In this study,the investigators will evaluate participants that have clinical features associated with an increased risk of esophageal disorders.The investigators will also see if there is a positive association of esophageal disorders in men,40-60 with or without abdominal obesity in the diagnosis of the following diseases; Gastroesophageal reflux disease, Barrett Esophagus and Esophageal Adenocarcinoma. The investigators hypothesize that most obese patients referred for Esophagogastroduodenoscopy will exhibit esophageal disorders. Since currently the rates of obesity and adenocarcinoma of the esophagus have increased significantly over the past 15 years, the investigators hope to find biochemical markers (i.e. pro-inflammatory mediators) in the esophagus. The investigators hope these samples will lead us to a differential expression of molecular markers and inflammatory mediators in the varying degrees of esophageal disorder

NCT ID: NCT02425033 Recruiting - Clinical trials for Esophageal Achalasia

POEM for Spastic Esophageal Disorders

Start date: April 2015
Phase: N/A
Study type: Interventional

This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM) technique for lower esophageal sphincter myotomy in patients suffering from spastic esophageal disorders such as achalasia at a Canadian institution. The investigators hypothesize that POEM is a safe and effective technique for the surgical management of such disorders at our institution.

NCT ID: NCT02105506 Completed - Gastric Disease Clinical Trials

Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses

SAFE-T
Start date: September 2012
Phase: N/A
Study type: Interventional

Rationale: The construction of esophageal anastomoses is associated with considerable risk at postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially prevent anastomotic leakage. Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal anastomoses. Study design: Non-randomized, non-blinded, single-center intervention study. Study population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be enrolled. A total number of 15 patients will be included in the study. Intervention: Gastric or esophageal resection will be executed according to the common procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will be degraded enzymatically in a period of approximately 24 weeks after application. Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by evaluation of adherence of the patch. A time-action analysis of the application of the Tachosil patch will be performed. Nature and extent of the burden associated with participation: The burden for the patient is minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative care and outpatient visits do not differ from regular protocol. TachoSil® is approved and registered for supportive treatment in surgery for improvement of haemostasis and to promote tissue sealing by the European Commission.