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

4. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

115

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Jorge Luis Núñez-Pizarro, MD
  • Telefonnummer: 3459 +34 932 27 54 00
  • E-post: jlnunez@clinic.cat

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Diagnostisk test: 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.

Andre navn:
  • Functional Lumen Imaging Probe
  • Impedance Planimetry
  • FLIP Panometry
Legemiddel: 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.

Andre navn:
  • BOTOX

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants With Clinical Response at 3 Months
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Response During Follow-up
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital Clinic of Barcelona

Samarbeidspartnere

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

7. desember 2026

Primær fullføring (Antatt)

6. mars 2029

Studiet fullført (Antatt)

6. desember 2029

Datoer for studieregistrering

Først innsendt

4. november 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HCB/2026/1095

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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