Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus SensationsNCT01056003
Prevalence of Gastric Inlet Patches of the Cervical Esophagus.
An observational study of Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations, run by Technical University of Munich at 1 site in Germany.
Trial summary
As known from several observational and retrospective endoscopic studies the prevalence of gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most cases GIPs are found within endoscopy as an incident finding, since in most cases they are harmless and do not cause any symptoms. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations
- What is being tested?
- Endoscopy
- How many people
- 4,000 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Jun 2011
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD
Who may be able to join
None listed.
Who cannot join
- emergency EGD
- any condition which contraindicates biopsy sampling
- unavailable informed consent for the GD
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar
Munich, Bavaria, 81675
Monther Bajbouj, MD, +49-89-41400, monther.bajbjouj@lrz.tum.de
About this study
Official title: Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations.
As known from several observational and retrospective endoscopic studies the prevalence of gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most cases GIPs are found within endoscopy as an incident finding, since in most cases they are harmless and do not cause any symptoms. None the less several data exist where an association between GIPs and globus sensations is discussed. Case reports even refer to bleeding complications and moreover to malignant transformations of GIPs.
As a result of the assumed association of GIPs and globus sensations we performed a pilot trial. Here we included 10 patients with globus and GIPs and were able to demonstrate a significant symptom relief after ablation of the GIP (Meining et al, Endoscopy 2006). To exclude a potential placebo-effect we concluded a multicenter and sham controlled trial where we imposingly were able to prove the symptom relief after ablation of the GIPs (Bajbouj et al, Gastroenterology 2009).
Read more
All patients, who are scheduled for esophagogastroduodenoscopy (EGD) in any of the above mentioned endoscopical departments are routinely standardized asked whether they have any hints suggestive for globus sensations (modified globus-questionnaire from Deary et al., J Psychosom Res 1995). Concurrently it is noted, whether the patients have endoscopical detected GIP. All GIPs are biopsied and examined in one institute. Together with anamnestic data (age, gender) a talley sheet gives a survey of all relevant information to prove or disprove following hypotheses.
Study hypotheses:
- The presence of GIPs is associated with globus sensations. In other words: Do patients with globus sensations significantly more often have GIPs?
- GIPs are not congenital, they arise in the course of the time and become symptomatic. In other words: Do GIPs significantly occur in more elderly people?
- The more increased the GIPs diameter is the more likely globus sensations are present? In other words: Do huge GIPs cause significantly more often symptoms than small ones?
- The more mucus-producing mucosa is histologically proven the more likely globus sensations are present? In other words: Do we find more cardiac mucosa in patients with symptoms than fundus mucosa?
- Being tested
- Endoscopy
- Keywords
- gastric inlet patch, prevalence, globus sensations
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyOther
observational endoscopy in all patients an EGD is planned anyway
| Study group | Role | What they receive |
|---|---|---|
| all patients admitting endoscopy for EGD | Not described Receives: Other: Endoscopy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus SensationsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München, Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München, Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm, Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
- Investigators
- Monther Bajbouj, MD, Principal investigator, Technical University MunichSybille Koletzko, Professor, Principal investigator, Kinderklinik im Dr. von Haunerschen Kinderspital, Universität MünchenSlim Saadi, MD, Principal investigator, Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; MünchenSusanne Liptay, MD, Principal investigator, Technical University MunichCarsten Posovsky, Principal investigator, University Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056003
- Sponsor's protocol ID
- Gips in Kids
- Status last verified
- Jan 2010
- First submitted
- 24 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bajbouj M, Becker V, Eckel F, Miehlke S, Pech O, Prinz C, Schmid RM, Meining A. Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology. 2009 Aug;137(2):440-4. doi: 10.1053/j.gastro.2009.04.053. Epub 2009 May 4.
PubMed 19410576Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70. doi: 10.1055/s-2006-925362.
PubMed 16802267
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations.
- ClinicalTrials.gov ID
- NCT01056003
- Acronym / sponsor ID
- Gips in Kids
- Keywords
- gastric inlet patch, prevalence, globus sensations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Institut für Allgemeine Pathologie und Pathologische Anatomie der TU München, Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München, Klinik für Kinder und Jugendmedizin, Universitätsklinikum Ulm, Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 26 Jan 2010 (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.
As known from several observational and retrospective endoscopic studies the prevalence of gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most cases GIPs are found within endoscopy as an incident finding, since in most cases they are harmless and do not cause any symptoms. None the less several data exist where an association between GIPs and globus sensations is discussed. Case reports even refer to bleeding complications and moreover to malignant transformations of GIPs.
As a result of the assumed association of GIPs and globus sensations we performed a pilot trial. Here we included 10 patients with globus and GIPs and were able to demonstrate a significant symptom relief after ablation of the GIP (Meining et al, Endoscopy 2006). To exclude a potential placebo-effect we concluded a multicenter and sham controlled trial where we imposingly were able to prove the symptom relief after ablation of the GIPs (Bajbouj et al, Gastroenterology 2009).
All patients, who are scheduled for esophagogastroduodenoscopy (EGD) in any of the above mentioned endoscopical departments are routinely standardized asked whether they have any hints suggestive for globus sensations (modified globus-questionnaire from Deary et al., J Psychosom Res 1995). Concurrently it is noted, whether the patients have endoscopical detected GIP. All GIPs are biopsied and examined in one institute. Together with anamnestic data (age, gender) a talley sheet gives a survey of all relevant information to prove or disprove following hypotheses.
Study hypotheses:
- The presence of GIPs is associated with globus sensations. In other words: Do patients with globus sensations significantly more often have GIPs?
- GIPs are not congenital, they arise in the course of the time and become symptomatic. In other words: Do GIPs significantly occur in more elderly people?
- The more increased the GIPs diameter is the more likely globus sensations are present? In other words: Do huge GIPs cause significantly more often symptoms than small ones?
- The more mucus-producing mucosa is histologically proven the more likely globus sensations are present? In other words: Do we find more cardiac mucosa in patients with symptoms than fundus mucosa?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients admitting endoscopy for EGD | – | Other: Endoscopy |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients admitting one of the above mentioned endoscopic departments for a scheduled EGD
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- emergency EGD
- any condition which contraindicates biopsy sampling
- unavailable informed consent for the GD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopyobservational endoscopy in all patients an EGD is planned anyway | Other | all patients admitting endoscopy for EGD |
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 26 Jan 2010.
- Results publication: PubMed 19410576Bajbouj M, Becker V, Eckel F, Miehlke S, Pech O, Prinz C, Schmid RM, Meining A. Argon plasma coagulation of cervical heterotopic gastric mucosa as an alternative treatment for globus sensations. Gastroenterology. 2009 Aug;137(2):440-4. doi: 10.1053/j.gastro.2009.04.053. Epub 2009 May 4.
- Results publication: PubMed 16802267Meining A, Bajbouj M, Preeg M, Reichenberger J, Kassem AM, Huber W, Brockmeyer SJ, Hannig C, Hofler H, Prinz C, Schmid RM. Argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy. 2006 Jun;38(6):566-70. doi: 10.1055/s-2006-925362.
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.
Monther Bajbouj, MD principal investigator
Technical University Munich
Sybille Koletzko, Professor principal investigator
Kinderklinik im Dr. von Haunerschen Kinderspital, Universität München
Slim Saadi, MD principal investigator
Klinik für Kinder und Jugendmedizin, Klinikum Dritter Orden; München
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 Association of Heterotopic Gastric Mucosa of the Cervical Esophagus and Globus Sensations, run by Technical University of Munich at 1 site in Germany.
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 0 inclusion and 3 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 26 Jan 2010. 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 Germany. 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 Monther Bajbouj, MD (+49-89-41400, monther.bajbouj@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056003, which also lists 2 linked publications.
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 26 Jan 2010.