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The Impact of Anesthetics on FLIP

Impact of Anesthetics on Esophageal Motility as Assessed by Functional Luminal Imaging Probe (FLIP) Topography

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07458555
Enrollment
30
Registered
2026-03-09
Start date
2024-11-22
Completion date
2026-07-01
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achalasia, Esophageal, Esophagogastric Junction Outflow Obstruction, Spastic Esophageal Disorders

Brief summary

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.

Interventions

DIAGNOSTIC_TESTFLIP 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.

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Distensibilityat 10 minFLIP Imaging EGJ metric Distensibility at 60 mL fill volume
Diameterat 10 minFLIP Imaging EGJ metric Diameter
Contractile Responseat 10 minContractile response category

Secondary

MeasureTime frameDescription
EGJ opening categoryat 10 minFLIP imaging EGJ opening category

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORVani A Konda, MD

Baylor Health Care System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026