Gastroesophageal RefluxNCT00482885
Coordination Versus Pressure in Oesophageal Peristalsis
An observational study of Gastroesophageal Reflux, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to Aug 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls and patients presenting with symptoms of reflux and endoscopy negative dysphagia
Who may be able to join
- Subjects to be included in the study are those:
- male or female
- at least 18 years of age
- have given informed consent for the HRM procedure
Who cannot join
- For normal controls:
- with symptoms or a history of oesophageal gastrointestinal disease
- with regular intake of medication. Occasional use of analgesic (e.g. aspirin) is allowed
- with any hematological abnormalities
- with any evidence of infectious disease
- who are pregnant or breast-feeding.
Show all 17Show fewer
- with evidence or history of drug or alcohol abuse within the past two years
- with diabetes mellitis
- with mental impairment limiting the ability to comply with study requirements
- who are taking or planning to take other investigational drugs during the study
- with use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics).
- with use of PPIs and H2 blockers
- For patients:
- with no oesophageal symptoms (e.g. referred for studies prior to bariatric surgery)
- with mental impairment limiting the ability to comply with study requirements
- who are taking or planning to take other investigational drugs during the study
- with use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oesophageal Laboratory, GSTT
London, London, SE1 7EH
About this study
Official title: The Effect of Position on Oesophageal Peristalsis and LOS Pressures: a High Resolution Manometry Study
High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. This allows not only contractile pressure to be measured, but also the coordination (proximal-distal) of contractions and the development of effective intra-bolus pressure (the force that drives bolus movement).
The study hypothesis is that (1) there will be a progressive increase in peristaltic pressure and decrease in velocity as the subjects move from the upright, through the supine to the upside down position and (2) the increase in pressure will be most evident in the mid-oesophagus at the transition zone between the striated and the smooth muscle contractions.
Read the detailed description
Introduction High Resolution Manometry (HRM) is an advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. This information can then be analysed either as conventional line plots or as a spatiotemporal plot, a compact, visually intuitive presentation of oesophageal pressure activity.1 This process has been quantified and verified in 75 normal volunteers.2 Increasing evidence suggests that HRM is a more sensitive and accurate means of assessing oesophageal function compared to conventional manometry.1 3 Compared to conventional manometry, HRM increases the accuracy with which the success of bolus transport can be predicted.1 This is important because oesophageal symptoms are more closely linked to impaired bolus transport than conventional pressure measurements per se.4
The additional information provided by HRM and the presentation of data as a spatiotemporal plot enable investigators to study the pressure activity in the oesophagus during normal eating behaviour for the first time. This study will assess the effects of position, bolus volume and consistency (liquid, solid). In addition, pressure activity during a standardized test meal will be observed.
Understanding the oesophageal response due to these 'physiologic challenges' is likely to be of clinical importance because most patients complain of swallowing problems, regurgitation or chest pain during such events and in the postprandial period. This is in contrast to standard manometry protocols that include the intake only of individual water, viscous fluid (e.g. yoghurt) or small, solid bolus swallows.
Healthy controls will be studies to provide normal data. Patients referred for investigation of oesophageal symptoms will be studied to assess whether physiologic challenge increases the ability to differentiate this group from normal controls, explain patient symptoms and increase diagnostic yield.
Effects of Position It is well known that transient lower oesophageal sphincter relaxations (TLOSRs) and reflux events are suppressed in the supine position in both healthy volunteers and in patients with mild-moderate reflux disease.7 The effects of position on oesophageal peristalsis and lower oesophageal sphincter pressure assessed by conventional manometry have been less consistent.
Recently HRM and video-fluoroscopy has been applied to study the effect of position and bolus consistency on oesophageal function.8 No effect of position on LOS pressure was found in these thin, healthy volunteers. In contrast peristaltic pressure increased and velocity decreased as the subject moved from the upright to the supine position. Similarly, peristaltic pressure increased and velocity decreased progressively as the subject took dry, water and solid swallows.8 These observations confirm combined manometry and impedance studies that show oesophageal function is not stereotyped but responds to the workload required for bolus transport. 5 67
Although findings are consistent for a given individual, variation in peristaltic contractile pressure is high and the correlation between peristaltic pressure and the success of bolus transport in healthy volunteers and patients is weak. Rather, preliminary observations by Fox et al. suggest that successful bolus transport, especially for solids, may depend more on effective coordination between proximal (striated) and mid-distal (smooth muscle) contractions than increased peristaltic pressure. In particular the prompt response of the mid-oesophageal segment appears to be linked to successful bolus transport through the oesophagus.8
Swallowed material can be transported successfully through the oesophagus in the upside down position. With the use of HRM, a detailed analysis of oesophageal peristalsis and bolus transport from the pharynx to the stomach is possible. We propose to explore the effect of 3 different positions (upright, supine and 60o head down) on the swallow of liquid and viscous material in healthy volunteers. Use of the extreme head down position provides a classical physiologic challenge that will highlight the oesophageal response to increased work against gravity.
Further events that increase oesophageal workload include the rapid intake of large volumes of fluid (i.e. free drinking) and the intake of solid food (i.e. test meal). Following the studies of position on oesophageal function, we will then assess the effect of drinking a standardized fluid load by multiple repeated swallows and intake of a standardized test meal on oesophageal and lower oesophageal sphincter function. Observations will be continued for 20minutes after ingestion to assess also oesophago-gastric function in the postprandial period.
Study hypothesis The driving force developed by oesophageal motor function 'increases' progressively with workload (e.g. increasing inclination, solid food) in healthy volunteers.
Hypothesis #1: This 'increase in driving force' will be more apparent and consistent as an increased in coordination of peristaltic contractions and development of intra-bolus pressure (i.e. endpoints assessed only by HRM) than effects on contractile pressure (i.e.; endpoints assessed also by conventional manometry).
Repeated swallowing during drinking suppresses oesophageal contractility. Hypothesis #2: Intermittent, coordinated and powerful peristaltic waves will be observed during a test meal and failure of this activity will result in raised intra-bolus pressure and symptoms (dysphagia, regurgitation, chest pain).
Hypothesis #3: Observations during and after a test meal will increase diagnostic yield for rumination and reflux related symptoms during stationary studies.
- Conditions
- Gastroesophageal Reflux
- Keywords
- Esophagus, Peristalsis, Contractile Pressure, Coordination of contraction, Bolus transport, Esophageal function
- Medical subject headings
- Gastroesophageal Reflux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Mark Fox, MD, Principal investigator, Honorary Consultant and Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482885
- Sponsor's protocol ID
- 07/Q0702/3
- Status last verified
- Jun 2011
- First submitted
- 1 Jun 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Position on Oesophageal Peristalsis and LOS Pressures: a High Resolution Manometry Study
- ClinicalTrials.gov ID
- NCT00482885
- Acronym / sponsor ID
- 07/Q0702/3
- Conditions
- Gastroesophageal Reflux
- Keywords
- Esophagus, Peristalsis, Contractile Pressure, Coordination of contraction, Bolus transport, Esophageal function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Jun 2007 (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.
High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. This allows not only contractile pressure to be measured, but also the coordination (proximal-distal) of contractions and the development of effective intra-bolus pressure (the force that drives bolus movement).
The study hypothesis is that (1) there will be a progressive increase in peristaltic pressure and decrease in velocity as the subjects move from the upright, through the supine to the upside down position and (2) the increase in pressure will be most evident in the mid-oesophagus at the transition zone between the striated and the smooth muscle contractions.
Detailed description
Introduction High Resolution Manometry (HRM) is an advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. This information can then be analysed either as conventional line plots or as a spatiotemporal plot, a compact, visually intuitive presentation of oesophageal pressure activity.1 This process has been quantified and verified in 75 normal volunteers.2 Increasing evidence suggests that HRM is a more sensitive and accurate means of assessing oesophageal function compared to conventional manometry.1 3 Compared to conventional manometry, HRM increases the accuracy with which the success of bolus transport can be predicted.1 This is important because oesophageal symptoms are more closely linked to impaired bolus transport than conventional pressure measurements per se.4
The additional information provided by HRM and the presentation of data as a spatiotemporal plot enable investigators to study the pressure activity in the oesophagus during normal eating behaviour for the first time. This study will assess the effects of position, bolus volume and consistency (liquid, solid). In addition, pressure activity during a standardized test meal will be observed.
Understanding the oesophageal response due to these 'physiologic challenges' is likely to be of clinical importance because most patients complain of swallowing problems, regurgitation or chest pain during such events and in the postprandial period. This is in contrast to standard manometry protocols that include the intake only of individual water, viscous fluid (e.g. yoghurt) or small, solid bolus swallows.
Healthy controls will be studies to provide normal data. Patients referred for investigation of oesophageal symptoms will be studied to assess whether physiologic challenge increases the ability to differentiate this group from normal controls, explain patient symptoms and increase diagnostic yield.
Effects of Position It is well known that transient lower oesophageal sphincter relaxations (TLOSRs) and reflux events are suppressed in the supine position in both healthy volunteers and in patients with mild-moderate reflux disease.7 The effects of position on oesophageal peristalsis and lower oesophageal sphincter pressure assessed by conventional manometry have been less consistent.
Recently HRM and video-fluoroscopy has been applied to study the effect of position and bolus consistency on oesophageal function.8 No effect of position on LOS pressure was found in these thin, healthy volunteers. In contrast peristaltic pressure increased and velocity decreased as the subject moved from the upright to the supine position. Similarly, peristaltic pressure increased and velocity decreased progressively as the subject took dry, water and solid swallows.8 These observations confirm combined manometry and impedance studies that show oesophageal function is not stereotyped but responds to the workload required for bolus transport. 5 67
Although findings are consistent for a given individual, variation in peristaltic contractile pressure is high and the correlation between peristaltic pressure and the success of bolus transport in healthy volunteers and patients is weak. Rather, preliminary observations by Fox et al. suggest that successful bolus transport, especially for solids, may depend more on effective coordination between proximal (striated) and mid-distal (smooth muscle) contractions than increased peristaltic pressure. In particular the prompt response of the mid-oesophageal segment appears to be linked to successful bolus transport through the oesophagus.8
Swallowed material can be transported successfully through the oesophagus in the upside down position. With the use of HRM, a detailed analysis of oesophageal peristalsis and bolus transport from the pharynx to the stomach is possible. We propose to explore the effect of 3 different positions (upright, supine and 60o head down) on the swallow of liquid and viscous material in healthy volunteers. Use of the extreme head down position provides a classical physiologic challenge that will highlight the oesophageal response to increased work against gravity.
Further events that increase oesophageal workload include the rapid intake of large volumes of fluid (i.e. free drinking) and the intake of solid food (i.e. test meal). Following the studies of position on oesophageal function, we will then assess the effect of drinking a standardized fluid load by multiple repeated swallows and intake of a standardized test meal on oesophageal and lower oesophageal sphincter function. Observations will be continued for 20minutes after ingestion to assess also oesophago-gastric function in the postprandial period.
Study hypothesis The driving force developed by oesophageal motor function 'increases' progressively with workload (e.g. increasing inclination, solid food) in healthy volunteers.
Hypothesis #1: This 'increase in driving force' will be more apparent and consistent as an increased in coordination of peristaltic contractions and development of intra-bolus pressure (i.e. endpoints assessed only by HRM) than effects on contractile pressure (i.e.; endpoints assessed also by conventional manometry).
Repeated swallowing during drinking suppresses oesophageal contractility. Hypothesis #2: Intermittent, coordinated and powerful peristaltic waves will be observed during a test meal and failure of this activity will result in raised intra-bolus pressure and symptoms (dysphagia, regurgitation, chest pain).
Hypothesis #3: Observations during and after a test meal will increase diagnostic yield for rumination and reflux related symptoms during stationary studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and patients presenting with symptoms of reflux and endoscopy negative dysphagia
Key inclusion criteria (4 listed)
- male or female
- at least 18 years of age
- have given informed consent for the HRM procedure
Key exclusion criteria (17 listed)
- with symptoms or a history of oesophageal gastrointestinal disease
- with regular intake of medication. Occasional use of analgesic (e.g. aspirin) is allowed
- with any hematological abnormalities
- with any evidence of infectious disease
- who are pregnant or breast-feeding.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Mark Fox, MD principal investigator
Honorary Consultant and Senior Lecturer
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 Gastroesophageal Reflux, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 17 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: finished, as of the sponsor's last update on 27 Jun 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 27 Jun 2011.