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Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease

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ClinicalTrials.gov Identifier: NCT03347903
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Gastroesophageal reflux disease (GERD) is involved in the development of esophageal motility disorders like Jackhammer esophagus (JE), a novel hypercontractile condition that was associated with progression to achalasia and limited outcomes following surgical anti-reflux therapy.

This trial was designed to assess the prevalence and characteristics of JE in patients with typical symptoms of GERD and responsiveness to PPI therapy.


Condition or disease
Esophageal Motility Disorders

Detailed Description:
Jackhammer esophagus is a novel hypercontractile esophageal disorder. The investigators assess the prevalence and clinical characteristics of patients diagnosed with this disorder out of a collective of patients that are referred with symptoms of gastroesphageal reflux disease and respond to PPI. This is an observational trial.

Study Design

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
Actual Study Start Date : January 1, 2014
Primary Completion Date : May 30, 2017
Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease [ Time Frame: January 2014- May 2017 ]
    All patients that are referred to our center with symptoms of gastroesophageal reflux disease routinely undergo high-resolution manometry. We assess how many patients are diagnosed with Jackhammer esophagus


Secondary Outcome Measures :
  1. Symptom perception [ Time Frame: January 2014- May 2017 ]
    We assess which symptoms are perceived by the patients diagnosed with Jackhammer esophagus. All data are observed during an interview at the high-resolution manometry

  2. Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus [ Time Frame: Januar 2014- May 2017 ]
    All patients that are referred to our center are evaluated for gastroesophageal reflux disease. We assess the prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus diagnosed by ambulatory pH monitoring.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients that are referred to our center undergo esophageal high-resolution manometry and ambulatory pH monitoring for screening of gastroesophageal reflux disease and motility disorders. We assess the data that are prospectively obtained. Patients do not have to undergo any interventions.
Criteria

Inclusion Criteria:

  • Patients with symptoms of gastroesophageal reflux disease and diagnosis of Jackhammer esophagus

Exclusion Criteria:

  • patients not willing to participate data or undergo screening for gastroesophageal reflux disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347903


Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sebastian Schoppmann, MD Vice Chair of Department of General Surgery
More Information

Responsible Party: Dr. Ivan Kristo, Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03347903     History of Changes
Other Study ID Numbers: 1164/2017
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Ivan Kristo, Medical University of Vienna:
esophagus
motility

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases