Achalasia, EsophagealNCT07458555
The Impact of Anesthetics on FLIP
A study of Achalasia, Esophageal and Esophagogastric Junction Outflow Obstruction, run by Baylor Research Institute at 1 site in United States.
Trial summary
To understand the impact of commonly used anesthetics on esophageal motility during FLIP topography. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Achalasia, Esophageal, Esophagogastric Junction Outflow Obstruction, Spastic Esophageal Disorders
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study subjects will include male and female patients age ≥18 to 75 years with dysphagia caused by achalasia (Type I, II or III) or by EGJ-outflow obstruction, suspected motility disorder, or undergoing an endoscopy to rule out an esophageal motility disorder who have been seen by Drs. Konda, Spechler, Nguyen, Reddy, Ellison, or Podgaetz. These patients will be undergoing an endoscopy and POEM procedure.
Who cannot join
- Age <18 or >75 years, patients unwilling or unable to provide informed consent; known gastrointestinal or thoracic or head and neck malignancy; known previous myotomy fundoplication, or other surgery involving the hiatus; and pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor University Medical Center - Jonsson Building
Dallas, Texas, 75246
About this study
Official title: Impact of Anesthetics on Esophageal Motility as Assessed by Functional Luminal Imaging Probe (FLIP) Topography
To understand the impact of commonly used anesthetics on esophageal motility during FLIP topography.
Read the detailed description
Achalasia is a disease of unknown etiology in which inflammatory cells destroy ganglion cells in the wall of the esophagus.[1,2 ] This inflammatory degeneration preferentially involves the inhibitory neurons in the esophageal myenteric plexus that are needed to effect normal peristalsis in the esophageal body and normal relaxation of the LES.[3] Thus, the classic manometric features of achalasia are: 1) absent esophageal peristalsis and 2) failure of the LES to relax with swallowing.[4] These physiologic abnormalities cause the typical achalasia symptom of dysphagia for both liquids and solids. No therapy is available to restore the lost esophageal ganglion cells in achalasia. Rather, treatments are directed at disrupting the LES muscle using invasive procedures that include pneumatic dilation, Heller myotomy, and per-oral endoscopic myotomy (POEM).
In 2008, using the technique of esophageal high resolution manometry, Pandolfino et al. identified three subtypes of achalasia.[5] In all three subtypes, there is no peristalsis and the LES does not relax normally with swallowing [recognized by an elevated integrated relaxation pressure (IRP) on high-resolution manometry]. In Type I achalasia, swallowing results in little or no distal esophageal pressurization. In Type II achalasia, swallowing is associated with panesophageal pressurization to a level >30 mm Hg. In Type III achalasia, swallowing is associated with spastic esophageal contractions. Patients with Type II achalasia have the best response to any form of achalasia treatment, whereas Type III patients have the worst response.
In the aforementioned study, the investigators also identified a group of patients who had abnormal LES relaxation with swallowing (i.e. an elevated IRP), but who had some preserved peristalsis in the body of the esophagus.[5] The investigators proposed that this was probably a heterogeneous group of patients, some having a variant form of achalasia and others having a mechanical obstruction at the esophago-gastric junction (EGJ). This manometrically-defined condition in which there is an elevated IRP with preserved peristalsis is now called EGJ-outflow obstruction.[6] A subset of patients with EGJ-outflow obstruction is a form of achalasia, likely due to the same process that causes esophageal ganglion cell loss in classic achalasia. There are additional spastic disorders of the esophagus such as diffuse esophageal spasm and hypercontractile esophagus.
Functional luminal imaging probe (FLIP) topography is a tool that has been increasingly helpful in characterization of patients with esophageal motor abnormalities, particularly those with achalasia, EGJOO and disorders with spastic elements.[7] In addition FLIP topography has been utilized to guide intervention and gauge adequacy of intervention pre and post myotomy. FLIP topography is now utilized in our standard algorithm for both diagnostic work ups of patients with motor diseases of the esophagus and during POEM procedures. During the course of some procedures, multiple FLIP assessments may be obtained for clinical purposes.
These patients with esophageal motor disorders are at increased risk of aspiration. We often perform endotracheal intubation for these patients with esophageal motor disorders to protect the airway and decrease the risk of aspiration. A common anesthetic gas is sevoflurane is used in endotracheal intubation. However, sevoflurane affects esophageal motility based on preliminary data from abstracts[8,9] but the appropriate anesthetic protocol with FLIP assessment remains unknown. Alternatives to sevoflurane include isoflurane or Propofol only sedation or total intravenous anesthesia (TIVA). Propofol only sedation is not thought to impact esophageal motility. The impact of isoflurane is unknown. At our institution we have generally performed FLIP topography assessments OFF sevoflurane. During the course of an entire procedure, both on and off gas may be used depending on the procedure and discretion of the anesthesia team. The exact impact of each anesthesia approach on the FLIP assessments.
To address the above-noted knowledge gaps in optimal sedation for FLIP topography achalasia and motility disorders of the esophagus, we propose to determine the impact of esophageal motility as assessed by FLIP topography.
- Conditions
- Achalasia, Esophageal, Esophagogastric Junction Outflow Obstruction, Spastic Esophageal Disorders
- Being tested
- FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.Diagnostic test
FLIP imaging will occur twice per subject with the same baseline (propofol) assessment and then a second study assessment with propofol, sevofluorane, or isofluorane.
| Study group | Role | What they receive |
|---|---|---|
| propofol-propofol | Placebo comparator | This is the control comparison of a subject undergoing FLIP imaging under the baseline scenario of propofol alone and then the again for a second time under propofol alone. Receives: Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation. |
| propofol-SEVO | Active comparator | This is the the study comparison group of a subject undergoing FLIP imaging under the baseline scenario of propofol alone and then the again for a second time but this time under the anesthetic gas sevofluorane. Receives: Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation. |
| propofol-ISO | Active comparator | This is the the study comparison group of a subject undergoing FLIP imaging under the baseline scenario of propofol alone and then the again for a second time but this time under the anesthetic gas isofluorane. Receives: Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distensibility
FLIP Imaging EGJ metric Distensibility at 60 mL fill volume
Measured: at 10 min
Diameter
FLIP Imaging EGJ metric Diameter
Measured: at 10 min
Contractile Response
Contractile response category
Measured: at 10 min
Secondary outcomes (1)
EGJ opening category
FLIP imaging EGJ opening category
Measured: at 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start22 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Achalasia, EsophagealStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vani Konda, Baylor Research Institute
- Investigators
- Vani A Konda, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458555
- Sponsor's protocol ID
- 024-122
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Benitez A, Jablonka DH, Sahu V, Gluckman C, DeMarshall M, Ostapenko S, Falk GW, Lynch KL, Menard-Katcher CD, Muir AB. Sevoflurane influences esophagogastric junction distensibility in the absence of esophageal inflammation. Gastrointest Endosc 2019; 89: AB 635,Tu 1968
Wellington J, Kim GE, Yang AH, Hwang DG, Kim RE. Effect of Anesthetics during endoflip impacts diagnosis of esophageal motility disorders. Gastrointest Endosc; 2020; 91: AB 133, Sa 1253
Donnan EN, Pandolfino JE. EndoFLIP in the Esophagus: Assessing Sphincter Function, Wall Stiffness, and Motility to Guide Treatment. Gastroenterol Clin North Am. 2020 Sep;49(3):427-435. doi: 10.1016/j.gtc.2020.04.002. Epub 2020 Jun 14.
PubMed 32718562Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.
PubMed 25469569Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008 Nov;135(5):1526-33. doi: 10.1053/j.gastro.2008.07.022. Epub 2008 Jul 22.
PubMed 18722376Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.
PubMed 25965233Holloway RH, Dodds WJ, Helm JF, Hogan WJ, Dent J, Arndorfer RC. Integrity of cholinergic innervation to the lower esophageal sphincter in achalasia. Gastroenterology. 1986 Apr;90(4):924-9. doi: 10.1016/0016-5085(86)90869-3.
PubMed 3949120Goldblum JR, Rice TW, Richter JE. Histopathologic features in esophagomyotomy specimens from patients with achalasia. Gastroenterology. 1996 Sep;111(3):648-54. doi: 10.1053/gast.1996.v111.pm8780569.
PubMed 8780569Goldblum JR, Whyte RI, Orringer MB, Appelman HD. Achalasia. A morphologic study of 42 resected specimens. Am J Surg Pathol. 1994 Apr;18(4):327-37.
PubMed 8141427
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthetics on Esophageal Motility as Assessed by Functional Luminal Imaging Probe (FLIP) Topography
- ClinicalTrials.gov ID
- NCT07458555
- Acronym / sponsor ID
- 024-122
- Conditions
- Achalasia, Esophageal, Esophagogastric Junction Outflow Obstruction, Spastic Esophageal Disorders
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Mar 2026 (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.
To understand the impact of commonly used anesthetics on esophageal motility during FLIP topography.
Detailed description
Achalasia is a disease of unknown etiology in which inflammatory cells destroy ganglion cells in the wall of the esophagus.[1,2 ] This inflammatory degeneration preferentially involves the inhibitory neurons in the esophageal myenteric plexus that are needed to effect normal peristalsis in the esophageal body and normal relaxation of the LES.[3] Thus, the classic manometric features of achalasia are: 1) absent esophageal peristalsis and 2) failure of the LES to relax with swallowing.[4] These physiologic abnormalities cause the typical achalasia symptom of dysphagia for both liquids and solids. No therapy is available to restore the lost esophageal ganglion cells in achalasia. Rather, treatments are directed at disrupting the LES muscle using invasive procedures that include pneumatic dilation, Heller myotomy, and per-oral endoscopic myotomy (POEM).
In 2008, using the technique of esophageal high resolution manometry, Pandolfino et al. identified three subtypes of achalasia.[5] In all three subtypes, there is no peristalsis and the LES does not relax normally with swallowing [recognized by an elevated integrated relaxation pressure (IRP) on high-resolution manometry]. In Type I achalasia, swallowing results in little or no distal esophageal pressurization. In Type II achalasia, swallowing is associated with panesophageal pressurization to a level >30 mm Hg. In Type III achalasia, swallowing is associated with spastic esophageal contractions. Patients with Type II achalasia have the best response to any form of achalasia treatment, whereas Type III patients have the worst response.
In the aforementioned study, the investigators also identified a group of patients who had abnormal LES relaxation with swallowing (i.e. an elevated IRP), but who had some preserved peristalsis in the body of the esophagus.[5] The investigators proposed that this was probably a heterogeneous group of patients, some having a variant form of achalasia and others having a mechanical obstruction at the esophago-gastric junction (EGJ). This manometrically-defined condition in which there is an elevated IRP with preserved peristalsis is now called EGJ-outflow obstruction.[6] A subset of patients with EGJ-outflow obstruction is a form of achalasia, likely due to the same process that causes esophageal ganglion cell loss in classic achalasia. There are additional spastic disorders of the esophagus such as diffuse esophageal spasm and hypercontractile esophagus.
Functional luminal imaging probe (FLIP) topography is a tool that has been increasingly helpful in characterization of patients with esophageal motor abnormalities, particularly those with achalasia, EGJOO and disorders with spastic elements.[7] In addition FLIP topography has been utilized to guide intervention and gauge adequacy of intervention pre and post myotomy. FLIP topography is now utilized in our standard algorithm for both diagnostic work ups of patients with motor diseases of the esophagus and during POEM procedures. During the course of some procedures, multiple FLIP assessments may be obtained for clinical purposes.
These patients with esophageal motor disorders are at increased risk of aspiration. We often perform endotracheal intubation for these patients with esophageal motor disorders to protect the airway and decrease the risk of aspiration. A common anesthetic gas is sevoflurane is used in endotracheal intubation. However, sevoflurane affects esophageal motility based on preliminary data from abstracts[8,9] but the appropriate anesthetic protocol with FLIP assessment remains unknown. Alternatives to sevoflurane include isoflurane or Propofol only sedation or total intravenous anesthesia (TIVA). Propofol only sedation is not thought to impact esophageal motility. The impact of isoflurane is unknown. At our institution we have generally performed FLIP topography assessments OFF sevoflurane. During the course of an entire procedure, both on and off gas may be used depending on the procedure and discretion of the anesthesia team. The exact impact of each anesthesia approach on the FLIP assessments.
To address the above-noted knowledge gaps in optimal sedation for FLIP topography achalasia and motility disorders of the esophagus, we propose to determine the impact of esophageal motility as assessed by FLIP topography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol-propofol | Placebo comparator | Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.This is the control comparison of a subject undergoing FLIP imaging under the baseline scenario of propofol alone and then the again for a second time under propofol alone. |
| propofol-SEVO | Active comparator | Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.This is the the study comparison group of a subject undergoing FLIP imaging under the baseline scenario of propofol alone and then the again for a second time but this time under the anesthetic gas sevofluorane. |
| propofol-ISO | Active comparator | Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.This is the the study comparison group of a subject undergoing FLIP imaging under the baseline scenario of propofol alone and then the again for a second time but this time under the anesthetic gas isofluorane. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study subjects will include male and female patients age ≥18 to 75 years with dysphagia caused by achalasia (Type I, II or III) or by EGJ-outflow obstruction, suspected motility disorder, or undergoing an endoscopy to rule out an esophageal motility disorder who have been seen by Drs. Konda, Spechler, Nguyen, Reddy, Ellison, or Podgaetz. These patients will be undergoing an endoscopy and POEM procedure.
Key exclusion criteria (1 listed)
- Age <18 or >75 years, patients unwilling or unable to provide informed consent; known gastrointestinal or thoracic or head and neck malignancy; known previous myotomy fundoplication, or other surgery involving the hiatus; and pregnancy.
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 |
|---|---|---|
| FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.FLIP imaging will occur twice per subject with the same baseline (propofol) assessment and then a second study assessment with propofol, sevofluorane, or isofluorane. | Diagnostic test | propofol-ISO, propofol-SEVO, propofol-propofol |
Primary outcome
Distensibility
Time frame: at 10 min
FLIP Imaging EGJ metric Distensibility at 60 mL fill volume
Diameter
Time frame: at 10 min
FLIP Imaging EGJ metric Diameter
Contractile Response
Time frame: at 10 min
Contractile response category
1 secondary outcome
EGJ opening category
Time frame: at 10 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- BackgroundBenitez A, Jablonka DH, Sahu V, Gluckman C, DeMarshall M, Ostapenko S, Falk GW, Lynch KL, Menard-Katcher CD, Muir AB. Sevoflurane influences esophagogastric junction distensibility in the absence of esophageal inflammation. Gastrointest Endosc 2019; 89: AB 635,Tu 1968
- BackgroundWellington J, Kim GE, Yang AH, Hwang DG, Kim RE. Effect of Anesthetics during endoflip impacts diagnosis of esophageal motility disorders. Gastrointest Endosc; 2020; 91: AB 133, Sa 1253
- Background: PubMed 32718562Donnan EN, Pandolfino JE. EndoFLIP in the Esophagus: Assessing Sphincter Function, Wall Stiffness, and Motility to Guide Treatment. Gastroenterol Clin North Am. 2020 Sep;49(3):427-435. doi: 10.1016/j.gtc.2020.04.002. Epub 2020 Jun 14.
- Background: PubMed 25469569Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.
- Background: PubMed 18722376Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008 Nov;135(5):1526-33. doi: 10.1053/j.gastro.2008.07.022. Epub 2008 Jul 22.
- Background: PubMed 25965233Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.
- Background: PubMed 3949120Holloway RH, Dodds WJ, Helm JF, Hogan WJ, Dent J, Arndorfer RC. Integrity of cholinergic innervation to the lower esophageal sphincter in achalasia. Gastroenterology. 1986 Apr;90(4):924-9. doi: 10.1016/0016-5085(86)90869-3.
- Background: PubMed 8780569Goldblum JR, Rice TW, Richter JE. Histopathologic features in esophagomyotomy specimens from patients with achalasia. Gastroenterology. 1996 Sep;111(3):648-54. doi: 10.1053/gast.1996.v111.pm8780569.
- Background: PubMed 8141427Goldblum JR, Whyte RI, Orringer MB, Appelman HD. Achalasia. A morphologic study of 42 resected specimens. Am J Surg Pathol. 1994 Apr;18(4):327-37.
- Individual participant dataSharing planned: Undecided
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Achalasia
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.
Vani A Konda, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Achalasia, Esophageal and Esophagogastric Junction Outflow Obstruction, run by Baylor Research Institute 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 9 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Distensibility (time frame: at 10 min). The study lists 3 primary outcomes in all. 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 NCT07458555, which also lists 9 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 9 Mar 2026.