NCT03347903

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

3.4 years

First QC Date

November 15, 2017

Last Update Submit

November 18, 2017

Conditions

Keywords

esophagusmotility

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Jackhammer esophagus in patients referred with symptoms of gastroesophageal reflux disease

    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

    January 2014- May 2017

Secondary Outcomes (2)

  • Symptom perception

    January 2014- May 2017

  • Prevalence of gastroesophageal reflux disease in patients with Jackhammer esophagus

    Januar 2014- May 2017

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kristo I, Schwameis K, Maschke S, Kainz A, Rieder E, Paireder M, Jomrich G, Schoppmann SF. Phenotypes of Jackhammer esophagus in patients with typical symptoms of gastroesophageal reflux disease responsive to proton pump inhibitors. Sci Rep. 2018 Jul 2;8(1):9949. doi: 10.1038/s41598-018-27756-9.

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Sebastian Schoppmann, MD

    Vice Chair of Department of General Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ.

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

January 1, 2014

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11