The Impact of Anesthetics on FLIP

NCT07458555 | Enrolling By Invitation FDA Device

• 1 other identifier: 024-122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To understand the impact of commonly used anesthetics on esophageal motility during FLIP topography.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Distensibility

  FLIP Imaging EGJ metric Distensibility at 60 mL fill volume

  at 10 min

• Diameter

  FLIP Imaging EGJ metric Diameter

  at 10 min

• Contractile Response

  Contractile response category

  at 10 min

Secondary Outcomes (1)

• EGJ opening category

  at 10 min

Study Arms (3)

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.

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.

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.

Diagnostic Test: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation.

Interventions

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.

propofol-ISO; propofol-SEVO; propofol-propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center - Jonsson Building

Dallas, Texas, 75246, United States

Location

Related Publications (9)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32718562 BACKGROUND

• Kahrilas 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.

  PMID: 25469569 BACKGROUND

• Pandolfino 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.

  PMID: 18722376 BACKGROUND

• Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996.

  PMID: 25965233 BACKGROUND

• Holloway 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.

  PMID: 3949120 BACKGROUND

• Goldblum 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.

  PMID: 8780569 BACKGROUND

• Goldblum 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.

  PMID: 8141427 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Vani A Konda, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: November 22, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)