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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT03347903
Collaborator
(none)
37
Enrollment
40.9
Actual Duration (Months)

Study Details

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 Intervention/Treatment Phase

    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 :
    Jan 1, 2014
    Actual Primary Completion Date :
    May 30, 2017
    Actual Study Completion Date :
    May 30, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Sebastian Schoppmann, MD, Vice Chair of Department of General Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Ivan Kristo, Dr. med. univ., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT03347903
    Other Study ID Numbers:
    • 1164/2017
    First Posted:
    Nov 20, 2017
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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, Dr. med. univ., Medical University of Vienna
    esophagus
    motility
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophageal Motility Disorders
    Esophageal Spasm, Diffuse

    Study Results

    No Results Posted as of Nov 21, 2017