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EndoFLIP-Guided Initial Management of Esophagogastric Junction Outflow Obstruction (O-FLIP)

4 novembre 2026 mis à jour par: Elizabeth Barba, Hospital Clinic of Barcelona

Prospective Evaluation of an Impedance Planimetry-Guided Therapeutic Stratification Algorithm in Patients With Esophagogastric Junction Outflow Obstruction After Endoscopic Assessment: O-FLIP Multicenter Study

Esophagogastric junction outflow obstruction (EGJOO) can make it difficult for food to pass from the esophagus into the stomach. Some people improve without a procedure to treat the obstruction, while others have persistent swallowing difficulties and may need further treatment.

The O-FLIP study tests whether measurements taken during an endoscopy with a tool called EndoFLIP can help doctors choose an initial treatment for adults with EGJOO. The main outcome is improvement in swallowing symptoms three months after initial management. The study will also track how long improvement lasts and how many participants need further treatment over one year.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

O-FLIP is a prospective, multicenter, nonrandomized, single-arm interventional study evaluating an EndoFLIP-guided initial management strategy for esophagogastric junction outflow obstruction (EGJOO). Specialist esophageal motility units in Spain will enroll consecutive adults with clinically relevant dysphagia who meet the study eligibility criteria. Baseline data will include clinical characteristics, symptom scores, and findings from high-resolution manometry, timed barium esophagram, upper gastrointestinal endoscopy, and EndoFLIP panometry.

Participating centers will receive common training and use a standardized protocol for EndoFLIP acquisition and interpretation based on the Dallas Consensus. The treating endoscopist will interpret EndoFLIP findings in real time to guide initial management. The coordinating center will subsequently review coded recordings to assess measurement quality and agreement with the local classification.

Symptoms and scores on the Brief Esophageal Dysphagia Questionnaire (BEDQ) and Eckardt score will be recorded at 1, 3, 6, and 12 months, along with treatment changes, dysphagia recurrence, adverse events, and treatment escalation. Follow-up will start on the date of botulinum toxin administration for participants who receive it and on the date of the index endoscopy for those initially managed conservatively.

The primary analysis will estimate the proportion of participants with clinical response at 3 months in the overall cohort, with a 95% confidence interval. Outcomes will also be summarized by baseline EndoFLIP category. Secondary analyses will assess the durability of response and time to definitive treatment directed at the esophagogastric junction. Among participants who receive botulinum toxin, exploratory analyses will examine baseline clinical and physiological factors associated with an incomplete or transient response and with subsequent definitive treatment. Additional exploratory analyses will examine how baseline timed barium esophagram findings relate to EndoFLIP findings and clinical outcomes.

Type d'étude

Interventionnel

Inscription (Estimé)

115

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Jorge Luis Núñez-Pizarro, MD
  • Numéro de téléphone: 3459 +34 932 27 54 00
  • E-mail: jlnunez@clinic.cat

Lieux d'étude

  • Espagne
    • Barcelona
      • Barcelona, Barcelona, Espagne, 08036
        • Hospital Clínic de Barcelona
        • Contact:
          • Jorge Luis Nuñez-Pizarro, MD
          • Numéro de téléphone: 3459 +34 932 27 54 00
          • E-mail: jlnunez@clinic.cat
        • Chercheur principal:
          • Jorge Luis Nuñez-Pizarro, MD
        • Sous-enquêteur:
          • Isis Karina Araujo, MD, PhD
        • Sous-enquêteur:
          • Elizabeth Barba Orozco, MD, PhD
        • Sous-enquêteur:
          • Gloria Fernández-Esparrach, MD, PhD
        • Sous-enquêteur:
          • Alberto Ezquerra, MD
    • Madrid
      • Madrid, Madrid, Espagne, 28041
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Chercheur principal:
          • Isabel Castel de Lucas, MD
      • Madrid, Madrid, Espagne, 28040
        • Hospital Clínico San Carlos
        • Contact:
        • Chercheur principal:
          • Constanza Ciriza de los Ríos, MD, PhD
        • Chercheur principal:
          • Ana Zatarain Valles, MD
      • Madrid, Madrid, Espagne
        • Hospital de La Princesa
        • Contact:
        • Chercheur principal:
          • Cecilio Santander Vaquero, MD, PhD
    • Majadahonda
      • Madrid, Majadahonda, Espagne, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
        • Contact:
        • Chercheur principal:
          • Rosalia González-Miyar, MD
    • Pamplona
      • Pamplona, Pamplona, Espagne, 31008
        • Hospital Universitario de Navarra
        • Contact:
        • Chercheur principal:
          • Fermin Estremera-Arévalo, MD, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age 18 years or older.
  • Written study-specific informed consent.
  • Clinically relevant dysphagia, defined as a Brief Esophageal Dysphagia Questionnaire (BEDQ) score of at least 8.
  • High-resolution manometry findings consistent with esophagogastric junction outflow obstruction (EGJOO) according to Chicago Classification version 4.0: elevated median integrated relaxation pressure in both the supine and upright positions, evidence of peristalsis, and intrabolus pressure greater than 20 mmHg in at least 20% of supine swallows, without meeting criteria for achalasia. Premature or hypercontractile contractions are permitted when peristalsis is present and criteria for type III achalasia are not met.

Exclusion Criteria:

  • Prior surgery or treatment directed at the esophagogastric junction, including botulinum toxin injection, pneumatic dilation, peroral endoscopic myotomy (POEM), Heller myotomy, or fundoplication.
  • Current opioid use unless opioids can be discontinued for at least 1 week before enrollment.
  • Hiatal hernia larger than 3 cm, peptic stricture, esophageal rings, esophagogastric malignancy, or any other mechanical cause of dysphagia. This includes a mechanical cause detected during the index endoscopy before EndoFLIP.
  • Eosinophilic esophagitis.
  • Systemic or infectious disease that significantly affects esophageal motility, such as systemic sclerosis or Chagas disease.
  • Inability to complete the planned clinical follow-up.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: EndoFLIP-Guided Clinical-Care Strategy

All participants will follow a standardized management algorithm based on esophagogastric junction (EGJ) opening on EndoFLIP panometry. Reduced opening will lead to botulinum toxin type A injection during the same endoscopy. Inconclusive or normal opening will lead to initial conservative management, which may include observation, proton pump inhibitors, neuromodulators, or calcium channel blockers at the treating physician's discretion.
Test diagnostique: EndoFLIP Panometry

EndoFLIP panometry will be performed during the index upper gastrointestinal endoscopy after mechanical causes of dysphagia have been excluded. The treating endoscopist will classify EGJ opening in real time according to standardized Dallas Consensus criteria. Coded recordings will subsequently undergo central review to assess measurement quality and agreement with the local classification.

Autres noms:
  • Functional Lumen Imaging Probe
  • Impedance Planimetry
  • FLIP Panometry
Médicament: Botulinum Toxin Type A (BOTOX) Injection

Botulinum toxin type A will be injected endoscopically into the lower esophageal sphincter in participants with reduced EGJ opening. The treating physician will be responsible for prescribing and administering the injection as part of the EndoFLIP-guided management strategy.

Autres noms:
  • BOTOX

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants With Clinical Response at 3 Months
Délai: 3 months after botulinum toxin administration or, for participants initially managed conservatively, 3 months after the index endoscopy.

Proportion of participants in the overall cohort with at least a 50% reduction from baseline in the Brief Esophageal Dysphagia Questionnaire (BEDQ) total score. BEDQ scores range from 0 to 40, with higher scores indicating more severe dysphagia.
3 months after botulinum toxin administration or, for participants initially managed conservatively, 3 months after the index endoscopy.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Clinical Response During Follow-up
Délai: Months 1, 6, and 12.

Proportion of participants with at least a 50% reduction from baseline in BEDQ total score.
Months 1, 6, and 12.
Change From Baseline in BEDQ Score
Délai: Baseline and months 1, 3, 6, and 12.

Change in BEDQ total score from baseline. Scores range from 0 to 40, with higher scores indicating more severe dysphagia.
Baseline and months 1, 3, 6, and 12.
Change From Baseline in Eckardt Score
Délai: Baseline and months 1, 3, 6, and 12.

Change in Eckardt symptom score from baseline. Scores range from 0 to 12, with higher scores indicating greater symptom burden.
Baseline and months 1, 3, 6, and 12.
Sustained Clinical Response
Délai: Months 3 through 12.

Proportion of participants with a clinical response at month 3 who maintain at least a 50% reduction from baseline in BEDQ score through month 12 without recurrence.
Months 3 through 12.
Dysphagia Recurrence After Clinical Response
Délai: From the first documented response through month 12.

Proportion of participants with a previously documented clinical response who subsequently have a BEDQ reduction of less than 50% from baseline.
From the first documented response through month 12.
Proportion of Participants Receiving Definitive EGJ-Directed Treatment
Délai: Through month 12.

Proportion of participants who undergo pneumatic dilation, peroral endoscopic myotomy, or Heller myotomy after initial management, and time from the start of follow-up to the first such treatment.
Through month 12.
Adverse Events Related to Procedures or Treatment
Délai: From the index endoscopy through month 12.

Proportion of participants with at least one adverse event associated with endoscopy, EndoFLIP, or treatment. Event severity will be reported using the AGREE classification, from grade I to V
From the index endoscopy through month 12.
Agreement Between Local and Central EndoFLIP Classification
Délai: Index endoscopy, with subsequent central review of the same recording.

Agreement on EGJ opening category (reduced, inconclusive, or normal), quantified using Cohen's kappa with a 95% confidence interval.
Index endoscopy, with subsequent central review of the same recording.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Clinic of Barcelona

Collaborateurs

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Les enquêteurs

  • Chercheur principal: Jorge Luis Núñez-Pizarro, MD, Hospital Clinic of Barcelona

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

7 décembre 2026

Achèvement primaire (Estimé)

6 mars 2029

Achèvement de l'étude (Estimé)

6 décembre 2029

Dates d'inscription aux études

Première soumission

4 novembre 2026

Première soumission répondant aux critères de contrôle qualité

4 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HCB/2026/1095

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

There is no plan to make individual participant data available to researchers outside the study team. Coded EndoFLIP recordings without direct participant identifiers will be transferred from participating sites to the coordinating center for central review as part of the study. The code key will remain at the originating site.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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