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Набор по приглашению NCT07458555

The Impact of Anesthetics on FLIP

Без фазы С лечением Achalasia, Esophageal Esophagogastric Junction Outflow Obstruction Spastic Esophageal Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FLIP Imaging under various standard of care anesthetics in the context of endotracheal intubation..
Кому может быть актуально
Состояния в реестре: Achalasia, Esophageal, Esophagogastric Junction Outflow Obstruction, Spastic Esophageal Disorders. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Distensibility [Срок оценки: at 10 min]
  • Diameter [Срок оценки: at 10 min]
  • Contractile Response [Срок оценки: at 10 min]
Вторичные конечные точки (1)
  • EGJ opening category [Срок оценки: at 10 min]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Baylor University Medical Center - Jonsson Building — Dallas

Публикации

  • 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. PMID 32718562
  • 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
  • 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
  • Pandolfino JE, Gawron AJ. Achalasia: a systematic review. JAMA. 2015 May 12;313(18):1841-52. doi: 10.1001/jama.2015.2996. PMID 25965233
  • 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
  • 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

Идентификаторы

NCT: NCT07458555 · 024-122

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗