GERD (Gastroesophageal Reflux Disease)NCT06973070
Upper GI MM vs Manometry
An observational study of GERD (Gastroesophageal Reflux Disease), run by Lexington Health Incorporated at 1 site in United States.
Trial summary
Research will consist of retrospective review of prospective cohort quantitative data collection with the goal of comparing preoperative High-Resolution Manometry (HRM) results to Upper Gastrointestinal Marshmallow (UGIMM) results, in the patient undergoing preoperative esophageal motility assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD (Gastroesophageal Reflux Disease)
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 20 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing preoperative testing for surgical intervention involving manipulation of the upper gastrointestinal tract.
Who may be able to join
- Preoperative patients who have undergone both HRM and UGIMM assessments as part of their preoperative plan of care.
- Patients who have had surgical procedures involving the upper GI tract and immediate surrounding structures after completing HRM and UGIMM assessments preoperatively.
- Adults aged 18 and older.
Who cannot join
- Patients who continued taking narcotics, calcium channel blockers, nitrates, or promotility medications the day of the HRM test, as these medications could falsely relax or hyper stimulate esophageal structures (Snyder \& Ravi, 2021).
- Patients with a past surgical history that includes Heller myotomy, peroral esophageal myotomy, botulinum injections, pneumatic dilations, or gastric fundoplication
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington Health Incorporated
West Columbia, South Carolina, 29169
About this study
Official title: Utilization of Upper GI Marshmallow Series Versus High Resolution Manometry in Preoperative Esophageal Motility Assessment
Research will consist of retrospective review of prospective cohort quantitative data collection with the goal of comparing preoperative High-Resolution Manometry (HRM) results to Upper Gastrointestinal Marshmallow (UGIMM) results, in the patient undergoing preoperative esophageal motility assessment. The aim of this study is to establish a correlation between HRM and UGIMM studies in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment. Research will examine the level of reliability and variability of the esophageal motility assessment conducted utilizing HRM and the UGIMM study. Standards of testing and current practice guidelines will be reviewed and compared for correlations in procedure outcomes. Research seeks to accomplish validation and strengthening of current practices related to the use and interpretation of HRM and UGIMM study results as a valid postoperative outcome predictor.
Read the detailed description
Identifying esophageal motility disorders prior to surgical intervention is imperative when determining the procedural route that will produce the greatest positive patient outcome and reduce postoperative sequelae related to preoperative conditions. Possible disparities have been identified between HRM and UGIMM assessment results. Identifying testing variables and standards that could impact the obtained results will allow providers the ability to create a more customized plan of care and increase outcome predictability. Therefore, examining HRM and UGIMM level of agreement is essential to providing the best evidence-based practice care and meeting the unique needs of individual patients.
Currently, HRM results are noted as the standard benchmark for adequate assessment of esophageal motility function and disorders. Esophageal manometry testing provides a means to determine if the esophagus is functioning properly through a series of wet swallows. As a patient swallows, the esophagus contracts in an orderly sequence to push the swallowed contents into the stomach. Once the contents enter the stomach, the Lower Esophageal Sphincter (LES) closes to prevent backflow, or reflux, of stomach contents into the esophagus. Any impairment to esophageal motility can compromise clearance and sphincter function, leading to adverse outcomes such as the development of intestinal metaplasia due to prolonged exposure of the mucosa to gastric acid. Assessment of motility and sphincter function is vital prior to any surgical intervention that involves manipulation of the gastroesophageal junction (GEJ) or surrounding structures. Inaccurate surgical manipulation can cause undesired pressure changes and alterations in normal peristalsis within the esophageal body.
By assessing preoperative baseline esophageal function, postoperative changes can be better predicted and adequacy of surgical intervention assessed. Some studies have noted that HRM metrics can predict overall surgical response and postoperative outcomes. Identification of motility dysfunction, or an incompetent LES, can be obtained during this examination, even in asymptomatic patients.
During HRM testing a flexible, small-bore probe will be passed via the nasal passages, down the esophagus and into the stomach. The patient is then asked to swallow a 5-milliliter saline fluid bolus while in the supine position for an average of 10 swallows. The test is then repeated in the standing, or upright, position for comparison. Pressure sensors on the probe record esophageal pressure, motility configurations, and contraction patterns. During the examination data is transmitted, via the probe, to a software program with the capability to autogenerate an analysis and diagnosis of the data. However, the autogenerated analysis can be situationally limited, therefore, the test administrator must possess a high level of understanding and keen interpretation skills to produce a completely accurate diagnosis. During study analysis it is often necessary to adjust anatomical markers, such as the location of the LES, Upper Esophageal Sphincter (UES), and the diaphragm, as the preset software data is unable to compensate for certain situational factors that may impact marker placement, such as GEJ morphology. The test administrator will identify and mark the UES, LES, and the pressure inversion point (PIP) during the interpretation phase. The integrated relaxation pressure (IRP) is then autocalculated, and provides a measurement of deglutitive relaxation during a 10 second time frame after the swallow is completed. The distal contractile integral (DCI) is also auto calculated and measures dynamism of peristalsis within the muscles of the esophagus. The PIP allows for evaluation of transition from the intra-abdominal cavity to the intrathoracic cavity. HRM results are categorized using the standardized Chicago Classification system which is subdivided into 4 hierarchical categories: 1) incomplete LES relaxation, 2) major motility disorders, 3) minor motility disorders, and 4) normal esophageal motility. Given that the test administrator has the ability to manipulate measurement markers during the analysis process, the need exists to identify possible gaps in consistency among test administrators, examine expected HRM results against other testing measures, such as the UGI MM test, and determine the impact the results have on patient outcomes.
A less invasive alternative to the HRM test is the UGIMM study. The UGIMM study is conducted under fluoroscopy and allows for the evaluation of motility function in real time, as well as visualization of anatomical structures. During the procedure radiographs are taken while the patient swallows a self-defined sip of barium in the standing position. The patient is then placed in the Trendelenburg position and asked to swallow a barium-soaked marshmallow while another set of radiographic images are taken. Each marshmallow measures the same, weighing approximately 6 grams. The UGIMM study currently does not have an established classification system by which result measurements are validated. However, exam outcomes are generally measured as follows: normal if the bolus clears the esophagus within 2 swallows or less; borderline swallowing dysfunction if the bolus clears within 3-4 swallows; abnormal swallowing function if 5 or more swallows are required to clear, or if a portion of the bolus remains after 5 swallows.
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Keywords
- GERD REFLUX GASTRIC REFLUX
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to establish a correlation between High Resolution Manometry and Upper Gastrointestinal Marshmallow studies to create a clinically supported gold standard measurement for preoperative esophageal motility assessment
Research will examine the level of reliability and variability of the esophageal motility assessment conducted utilizing High Resolution Manometry and the Upper Gastrointestinal Marshmallow study. Standards of testing and current practice guidelines will be reviewed and compared for correlations in procedure outcomes. Research seeks to accomplish validation and strengthening of current practices related to the use and interpretation of High Resolution Manometry and Upper Gastrointestinal Marshmallow study results as a valid postoperative outcome predictor.
Measured: September 2020-April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start17 Mar 2025
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GERD (Gastroesophageal Reflux Disease)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexington Health Incorporated
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Antonetti, MD, Lexington Health Incorporated
- Investigators
- Marc Antonetti, MD, Principal investigator, Lexington Health Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973070
- Sponsor's protocol ID
- LMCII2025-003
- Status last verified
- Mar 2025
- First submitted
- 5 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Musella M, Vitiello A, Berardi G, Velotti N, Pesce M, Sarnelli G. Evaluation of reflux following sleeve gastrectomy and one anastomosis gastric bypass: 1-year results from a randomized open-label controlled trial. Surg Endosc. 2021 Dec;35(12):6777-6785. doi: 10.1007/s00464-020-08182-3. Epub 2020 Dec 2.
PubMed 33269429FalcAo AM, Nasi A, Szachnowicz S, Santa-Cruz F, Seguro FCBC, Sena BF, Duarte A, Sallum RA, Cecconello I. Does the nissen fundoplication procedure improve esophageal dysmotility in patients with barrett's esophagus? Rev Col Bras Cir. 2020 Nov 30;47:e20202637. doi: 10.1590/0100-6991e-20202637. eCollection 2020. English, Portuguese.
PubMed 33263652Yadlapati R. High-resolution esophageal manometry: interpretation in clinical practice. Curr Opin Gastroenterol. 2017 Jul;33(4):301-309. doi: 10.1097/MOG.0000000000000369.
PubMed 28426462
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Upper GI Marshmallow Series Versus High Resolution Manometry in Preoperative Esophageal Motility Assessment
- ClinicalTrials.gov ID
- NCT06973070
- Acronym / sponsor ID
- LMCII2025-003
- Conditions
- GERD (Gastroesophageal Reflux Disease)
- Keywords
- GERD REFLUX GASTRIC REFLUX
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Lexington Health IncorporatedUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 15 May 2025 (actual)
- 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.
Research will consist of retrospective review of prospective cohort quantitative data collection with the goal of comparing preoperative High-Resolution Manometry (HRM) results to Upper Gastrointestinal Marshmallow (UGIMM) results, in the patient undergoing preoperative esophageal motility assessment. The aim of this study is to establish a correlation between HRM and UGIMM studies in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment. Research will examine the level of reliability and variability of the esophageal motility assessment conducted utilizing HRM and the UGIMM study. Standards of testing and current practice guidelines will be reviewed and compared for correlations in procedure outcomes. Research seeks to accomplish validation and strengthening of current practices related to the use and interpretation of HRM and UGIMM study results as a valid postoperative outcome predictor.
Detailed description
Identifying esophageal motility disorders prior to surgical intervention is imperative when determining the procedural route that will produce the greatest positive patient outcome and reduce postoperative sequelae related to preoperative conditions. Possible disparities have been identified between HRM and UGIMM assessment results. Identifying testing variables and standards that could impact the obtained results will allow providers the ability to create a more customized plan of care and increase outcome predictability. Therefore, examining HRM and UGIMM level of agreement is essential to providing the best evidence-based practice care and meeting the unique needs of individual patients.
Currently, HRM results are noted as the standard benchmark for adequate assessment of esophageal motility function and disorders. Esophageal manometry testing provides a means to determine if the esophagus is functioning properly through a series of wet swallows. As a patient swallows, the esophagus contracts in an orderly sequence to push the swallowed contents into the stomach. Once the contents enter the stomach, the Lower Esophageal Sphincter (LES) closes to prevent backflow, or reflux, of stomach contents into the esophagus. Any impairment to esophageal motility can compromise clearance and sphincter function, leading to adverse outcomes such as the development of intestinal metaplasia due to prolonged exposure of the mucosa to gastric acid. Assessment of motility and sphincter function is vital prior to any surgical intervention that involves manipulation of the gastroesophageal junction (GEJ) or surrounding structures. Inaccurate surgical manipulation can cause undesired pressure changes and alterations in normal peristalsis within the esophageal body.
By assessing preoperative baseline esophageal function, postoperative changes can be better predicted and adequacy of surgical intervention assessed. Some studies have noted that HRM metrics can predict overall surgical response and postoperative outcomes. Identification of motility dysfunction, or an incompetent LES, can be obtained during this examination, even in asymptomatic patients.
During HRM testing a flexible, small-bore probe will be passed via the nasal passages, down the esophagus and into the stomach. The patient is then asked to swallow a 5-milliliter saline fluid bolus while in the supine position for an average of 10 swallows. The test is then repeated in the standing, or upright, position for comparison. Pressure sensors on the probe record esophageal pressure, motility configurations, and contraction patterns. During the examination data is transmitted, via the probe, to a software program with the capability to autogenerate an analysis and diagnosis of the data. However, the autogenerated analysis can be situationally limited, therefore, the test administrator must possess a high level of understanding and keen interpretation skills to produce a completely accurate diagnosis. During study analysis it is often necessary to adjust anatomical markers, such as the location of the LES, Upper Esophageal Sphincter (UES), and the diaphragm, as the preset software data is unable to compensate for certain situational factors that may impact marker placement, such as GEJ morphology. The test administrator will identify and mark the UES, LES, and the pressure inversion point (PIP) during the interpretation phase. The integrated relaxation pressure (IRP) is then autocalculated, and provides a measurement of deglutitive relaxation during a 10 second time frame after the swallow is completed. The distal contractile integral (DCI) is also auto calculated and measures dynamism of peristalsis within the muscles of the esophagus. The PIP allows for evaluation of transition from the intra-abdominal cavity to the intrathoracic cavity. HRM results are categorized using the standardized Chicago Classification system which is subdivided into 4 hierarchical categories: 1) incomplete LES relaxation, 2) major motility disorders, 3) minor motility disorders, and 4) normal esophageal motility. Given that the test administrator has the ability to manipulate measurement markers during the analysis process, the need exists to identify possible gaps in consistency among test administrators, examine expected HRM results against other testing measures, such as the UGI MM test, and determine the impact the results have on patient outcomes.
A less invasive alternative to the HRM test is the UGIMM study. The UGIMM study is conducted under fluoroscopy and allows for the evaluation of motility function in real time, as well as visualization of anatomical structures. During the procedure radiographs are taken while the patient swallows a self-defined sip of barium in the standing position. The patient is then placed in the Trendelenburg position and asked to swallow a barium-soaked marshmallow while another set of radiographic images are taken. Each marshmallow measures the same, weighing approximately 6 grams. The UGIMM study currently does not have an established classification system by which result measurements are validated. However, exam outcomes are generally measured as follows: normal if the bolus clears the esophagus within 2 swallows or less; borderline swallowing dysfunction if the bolus clears within 3-4 swallows; abnormal swallowing function if 5 or more swallows are required to clear, or if a portion of the bolus remains after 5 swallows.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing preoperative testing for surgical intervention involving manipulation of the upper gastrointestinal tract.
Key inclusion criteria (3 listed)
- Preoperative patients who have undergone both HRM and UGIMM assessments as part of their preoperative plan of care.
- Patients who have had surgical procedures involving the upper GI tract and immediate surrounding structures after completing HRM and UGIMM assessments preoperatively.
- Adults aged 18 and older.
Key exclusion criteria (2 listed)
- Patients who continued taking narcotics, calcium channel blockers, nitrates, or promotility medications the day of the HRM test, as these medications could falsely relax or hyper stimulate esophageal structures (Snyder \& Ravi, 2021).
- Patients with a past surgical history that includes Heller myotomy, peroral esophageal myotomy, botulinum injections, pneumatic dilations, or gastric fundoplication
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
The aim of this study is to establish a correlation between High Resolution Manometry and Upper Gastrointestinal Marshmallow studies to create a clinically supported gold standard measurement for preoperative esophageal motility assessment
Time frame: September 2020-April 2024
Research will examine the level of reliability and variability of the esophageal motility assessment conducted utilizing High Resolution Manometry and the Upper Gastrointestinal Marshmallow study. Standards of testing and current practice guidelines will be reviewed and compared for correlations in procedure outcomes. Research seeks to accomplish validation and strengthening of current practices related to the use and interpretation of High Resolution Manometry and Upper Gastrointestinal Marshmallow study results as a valid postoperative outcome predictor.
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 15 May 2025.
- Background: PubMed 33269429Musella M, Vitiello A, Berardi G, Velotti N, Pesce M, Sarnelli G. Evaluation of reflux following sleeve gastrectomy and one anastomosis gastric bypass: 1-year results from a randomized open-label controlled trial. Surg Endosc. 2021 Dec;35(12):6777-6785. doi: 10.1007/s00464-020-08182-3. Epub 2020 Dec 2.
- Background: PubMed 33263652FalcAo AM, Nasi A, Szachnowicz S, Santa-Cruz F, Seguro FCBC, Sena BF, Duarte A, Sallum RA, Cecconello I. Does the nissen fundoplication procedure improve esophageal dysmotility in patients with barrett's esophagus? Rev Col Bras Cir. 2020 Nov 30;47:e20202637. doi: 10.1590/0100-6991e-20202637. eCollection 2020. English, Portuguese.
- Background: PubMed 28426462Yadlapati R. High-resolution esophageal manometry: interpretation in clinical practice. Curr Opin Gastroenterol. 2017 Jul;33(4):301-309. doi: 10.1097/MOG.0000000000000369.
- Related InfoLink provided by the sponsor.
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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.
Marc Antonetti, MD principal investigator
Lexington Health Incorporated
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 GERD (Gastroesophageal Reflux Disease), run by Lexington Health Incorporated at 1 site in United States.
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: finished, as of the sponsor's last update on 15 May 2025. 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 States. 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.
What does the primary outcome measure?
The aim of this study is to establish a correlation between High Resolution Manometry and Upper Gastrointestinal Marshmallow studies to create a clinically supported gold standard measurement for preoperative esophageal motility assessment (time frame: September 2020-April 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973070, which also lists 3 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 15 May 2025.