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

4 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

115

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jorge Luis Núñez-Pizarro, MD
  • Telefoonnummer: 3459 +34 932 27 54 00
  • E-mail: jlnunez@clinic.cat

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Diagnostische toets: 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.

Andere namen:
  • Functional Lumen Imaging Probe
  • Impedance Planimetry
  • FLIP Panometry
Geneesmiddel: 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.

Andere namen:
  • BOTOX

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Participants With Clinical Response at 3 Months
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical Response During Follow-up
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Clinic of Barcelona

Medewerkers

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

7 december 2026

Primaire voltooiing (Geschat)

6 maart 2029

Studie voltooiing (Geschat)

6 december 2029

Studieregistratiedata

Eerst ingediend

4 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 november 2026

Eerst geplaatst (Werkelijk)

10 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HCB/2026/1095

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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