Esophageal Motility DisordersNCT01447823
Observational Field Study of Acute Esophageal Food Bolus Impaction by Mean Esophageal Manometry and 24h-pH-monitoring
An observational study of Esophageal Motility Disorders, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate standard investigations performed in patients with bolus impaction in a prospective observational field study. In bolus impaction, ingested food boluses have to be endoscopically removed. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Motility Disorders
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing upper endoscopy for removal of a food bolus are asked to sign the standard clinical informed consent form for interventional endoscopy of the Division of Gastroenterology at the University Hospital Zurich. After Diagnosis of food impaction has been made, the food bolus has been removed and the endoscopy has been completed, the patient will be informed of the Diagnosis and the standard procedure of care (High resolution manometry, pH-monitoring, blood sampling) will be explained, and an appointment for these procedures will be given (1-4days thereafter).
Who may be able to join
- Patients with acute esophageal bolus impaction coming to the emergency unit of the University Hospital Zurich needing emergency endoscopy for bolus removal
- Age > 18 years
- Informed consent
Who cannot join
- Age under 18 years
- Inability to understand the informed consent form
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Gastroenterology and Hepatology
Zurich
About this study
The aim of this study is to evaluate standard investigations performed in patients with bolus impaction in a prospective observational field study. In bolus impaction, ingested food boluses have to be endoscopically removed. Oesophageal narrowing by scar tissue caused by reflux disease or motility disorders are possible causes of bolus impaction. How common these causes are has up to date never been investigated. The discovery of eosinophilic oesophagitis has broadened differential diagnosis of bolus impaction. Currently high resolution oesophageal manometry and 24-hour pHmetry are performed in addition to endoscopy in the assessment of bolus impaction at the University Hospital Zurich.
The collection of these examination results is the aim of this prospective unrandomised observational field study to assess weather the currently applied procedures are valid to diagnose the cause of impaction to find optimal therapy for each patient.
Read the detailed description
The key function of the esophagus ist (i) the immediate transport of the food bolus from the mouth to the stomach and (ii) to inhibit reflux from the stomach back to the esophagus.
Motility disorders of the esophagus lead to an impaired bolus transport and/or reflux of stomach content to the esophagus, and may cause symptoms such as (obstructive) dysphagia, chest pain, heart burn and/or regurgitation.
Acute esophageal food impaction is a common acute condition of the upper GI tract that usually needs immediate medical attention. The food bolus, e.g. a peace of red meat or similar is blocked within the tubular part of the esophagus, e.g. proximal to the esophagogastric junction and neither passes spontaneously into the stomach nor can be regurgitated actively. In this case it usually requires upper endoscopy for endoscopic removal of the food bolus.
Possible causes of food impaction are (i) structural obstruction within the esophagus such as a Schatzki's ring, an esophageal web, a peptic stenosis secondary to gastroesophageal reflux disease, or more rarely esophageal carcinoma [1, 2]; (ii) functional causes of obstruction are mainly Achalasia or Esophageal Esophagitis (EE). In Achalasia a idiopathic neurodegenerative destruction of the inhibitory neurons of the esophagus leads to a failure of the lower esophageal sphincter to relax and an impaired esophageal peristalsis. Patients usually present with a history of progressive dysphagia and regurgitation of undigested food, but rarely a food impaction can occur [3]. Eosinophilic Esophagitis is a idiopathic disorder in which eosinophilic infiltration of the mucosal wall leads to an impaired esophageal motility, which usually causes dysphagia, retrosternal pain or food bolus impaction.[3] Its etiology remains unknown but several studies suggest an allergic response to food and allergens. Previously believed to be a rather rare disease and therefore rare cause for bolus impaction, eosinophilic esophagitis has emerged as one of the most common causes for food impaction and dysphagia in general [4]. The increase in prevalence is not entirely clear; besides better recognition by gastroenterologists and pathologists there seems to be a true increase in incidence, probably due to an increased incidence of allergic diseases [5]. Its diagnosis is difficult due to other causes of eosinophilic infiltrate such as gastroesophageal reflux disease or eosinophilic gastroenteritis[3].
The reason for an impaired motility in EE is unknown, although several hypothetic mechanisms are discussed [6]: (i) increased contraction of fibroblast secondary to presence of eosinophilic granulocytes, (ii) axonal necrosis secondary to eosinophilic degradation (iii) binding of eosinophil derived MBP (major basic protein) to muscarinic acetylcholine receptors leading to increased contraction.
The true prevalence of eosinophilic esophagitis in patients with food impaction remains unknown. Desai et al evaluated 31 patients with acute bolus impaction of which more than 50% had an increased count of intraesophageal eosinophils per high power field [4]. However, the true share of EE remains unclear. Especially the amount of patients with eosinophilic infiltrate due to gastroesophageal reflux is not defined (half of all patients had PPI before endoscopy).
The current clinical standard of care for patients with food bolus impaction at the Division of Gastroenterology at the University Hospital Zurich includes
- endoscopy to i) remove the food bolus; ii) take esophageal, gastric and duodenal biopsies to assess histological abnormalities and iii) assess structural causes for obstruction;
- a high resolution esophageal manometry (HRM) to assess esophageal motility;
- an ambulatory intraesophageal pH-monitoring to asses esophageal acid exposure and
- venous blood sampling to assess eosinophilic count in peripheral blood.
These procedures are considered to be both i) necessary as well as ii) sufficient and accurate to elucidate the true cause of bolus impaction [3]. Our aim is now to objectify this standard procedure of care in an open, prospective, observational, unrandomized field study. It is important to mention that all procedures have been and are indicated in this situation as current standard procedure of care to assess patients with bolus impaction; they should be performed whether the patient is included in our field study or not. Therefore participation in the study does not lead to any additional diagnostic or therapeutic procedures/interventions
- Conditions
- Esophageal Motility Disorders
- Keywords
- Oesophageal bolus obstruction, Gastroscopy, phmetry
- Medical subject headings
- Esophageal Motility Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital ZuerichMichael Fried, Professor, MD, Principal investigator, University Hospital Zurich, Division of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447823
- Sponsor's protocol ID
- KEK-ZH Nr 2011-0192
- Status last verified
- Oct 2011
- First submitted
- 27 Sep 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Field Study of Acute Esophageal Food Bolus Impaction by Mean Esophageal Manometry and 24h-pH-monitoring
- ClinicalTrials.gov ID
- NCT01447823
- Acronym / sponsor ID
- KEK-ZH Nr 2011-0192
- Conditions
- Esophageal Motility Disorders
- Keywords
- Oesophageal bolus obstruction, Gastroscopy, phmetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate standard investigations performed in patients with bolus impaction in a prospective observational field study. In bolus impaction, ingested food boluses have to be endoscopically removed. Oesophageal narrowing by scar tissue caused by reflux disease or motility disorders are possible causes of bolus impaction. How common these causes are has up to date never been investigated. The discovery of eosinophilic oesophagitis has broadened differential diagnosis of bolus impaction. Currently high resolution oesophageal manometry and 24-hour pHmetry are performed in addition to endoscopy in the assessment of bolus impaction at the University Hospital Zurich.
The collection of these examination results is the aim of this prospective unrandomised observational field study to assess weather the currently applied procedures are valid to diagnose the cause of impaction to find optimal therapy for each patient.
Detailed description
The key function of the esophagus ist (i) the immediate transport of the food bolus from the mouth to the stomach and (ii) to inhibit reflux from the stomach back to the esophagus.
Motility disorders of the esophagus lead to an impaired bolus transport and/or reflux of stomach content to the esophagus, and may cause symptoms such as (obstructive) dysphagia, chest pain, heart burn and/or regurgitation.
Acute esophageal food impaction is a common acute condition of the upper GI tract that usually needs immediate medical attention. The food bolus, e.g. a peace of red meat or similar is blocked within the tubular part of the esophagus, e.g. proximal to the esophagogastric junction and neither passes spontaneously into the stomach nor can be regurgitated actively. In this case it usually requires upper endoscopy for endoscopic removal of the food bolus.
Possible causes of food impaction are (i) structural obstruction within the esophagus such as a Schatzki's ring, an esophageal web, a peptic stenosis secondary to gastroesophageal reflux disease, or more rarely esophageal carcinoma [1, 2]; (ii) functional causes of obstruction are mainly Achalasia or Esophageal Esophagitis (EE). In Achalasia a idiopathic neurodegenerative destruction of the inhibitory neurons of the esophagus leads to a failure of the lower esophageal sphincter to relax and an impaired esophageal peristalsis. Patients usually present with a history of progressive dysphagia and regurgitation of undigested food, but rarely a food impaction can occur [3]. Eosinophilic Esophagitis is a idiopathic disorder in which eosinophilic infiltration of the mucosal wall leads to an impaired esophageal motility, which usually causes dysphagia, retrosternal pain or food bolus impaction.[3] Its etiology remains unknown but several studies suggest an allergic response to food and allergens. Previously believed to be a rather rare disease and therefore rare cause for bolus impaction, eosinophilic esophagitis has emerged as one of the most common causes for food impaction and dysphagia in general [4]. The increase in prevalence is not entirely clear; besides better recognition by gastroenterologists and pathologists there seems to be a true increase in incidence, probably due to an increased incidence of allergic diseases [5]. Its diagnosis is difficult due to other causes of eosinophilic infiltrate such as gastroesophageal reflux disease or eosinophilic gastroenteritis[3].
The reason for an impaired motility in EE is unknown, although several hypothetic mechanisms are discussed [6]: (i) increased contraction of fibroblast secondary to presence of eosinophilic granulocytes, (ii) axonal necrosis secondary to eosinophilic degradation (iii) binding of eosinophil derived MBP (major basic protein) to muscarinic acetylcholine receptors leading to increased contraction.
The true prevalence of eosinophilic esophagitis in patients with food impaction remains unknown. Desai et al evaluated 31 patients with acute bolus impaction of which more than 50% had an increased count of intraesophageal eosinophils per high power field [4]. However, the true share of EE remains unclear. Especially the amount of patients with eosinophilic infiltrate due to gastroesophageal reflux is not defined (half of all patients had PPI before endoscopy).
The current clinical standard of care for patients with food bolus impaction at the Division of Gastroenterology at the University Hospital Zurich includes
- endoscopy to i) remove the food bolus; ii) take esophageal, gastric and duodenal biopsies to assess histological abnormalities and iii) assess structural causes for obstruction;
- a high resolution esophageal manometry (HRM) to assess esophageal motility;
- an ambulatory intraesophageal pH-monitoring to asses esophageal acid exposure and
- venous blood sampling to assess eosinophilic count in peripheral blood.
These procedures are considered to be both i) necessary as well as ii) sufficient and accurate to elucidate the true cause of bolus impaction [3]. Our aim is now to objectify this standard procedure of care in an open, prospective, observational, unrandomized field study. It is important to mention that all procedures have been and are indicated in this situation as current standard procedure of care to assess patients with bolus impaction; they should be performed whether the patient is included in our field study or not. Therefore participation in the study does not lead to any additional diagnostic or therapeutic procedures/interventions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing upper endoscopy for removal of a food bolus are asked to sign the standard clinical informed consent form for interventional endoscopy of the Division of Gastroenterology at the University Hospital Zurich. After Diagnosis of food impaction has been made, the food bolus has been removed and the endoscopy has been completed, the patient will be informed of the Diagnosis and the standard procedure of care (High resolution manometry, pH-monitoring, blood sampling) will be explained, and an appointment for these procedures will be given (1-4days thereafter).
Key inclusion criteria (3 listed)
- Patients with acute esophageal bolus impaction coming to the emergency unit of the University Hospital Zurich needing emergency endoscopy for bolus removal
- Age > 18 years
- Informed consent
Key exclusion criteria (2 listed)
- Age under 18 years
- Inability to understand the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
Related trials for Esophageal Motility Disorders
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
Michael Fried, Professor, MD principal investigator
University Hospital Zurich, Division of Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Steingoetter (+41 (0)44 255 5684, andreas.steingoetter@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.