EndoFLIP-Guided Initial Management of Esophagogastric Junction Outflow Obstruction (O-FLIP)
4 de noviembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
115
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Jorge Luis Núñez-Pizarro, MD
- Número de teléfono: 3459 +34 932 27 54 00
- Correo electrónico: jlnunez@clinic.cat
Ubicaciones de estudio
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Barcelona
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Barcelona, Barcelona, España, 08036
- Hospital Clínic de Barcelona
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Contacto:
- Jorge Luis Nuñez-Pizarro, MD
- Número de teléfono: 3459 +34 932 27 54 00
- Correo electrónico: jlnunez@clinic.cat
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Investigador principal:
- Jorge Luis Nuñez-Pizarro, MD
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Sub-Investigador:
- Isis Karina Araujo, MD, PhD
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Sub-Investigador:
- Elizabeth Barba Orozco, MD, PhD
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Sub-Investigador:
- Gloria Fernández-Esparrach, MD, PhD
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Sub-Investigador:
- Alberto Ezquerra, MD
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Madrid
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Madrid, Madrid, España, 28041
- Hospital Universitario 12 de Octubre
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Contacto:
- Isabel Castel de Lucas, MD
- Número de teléfono: +34 913 90 80 00
- Correo electrónico: aromeror@salud.madrid.org
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Investigador principal:
- Isabel Castel de Lucas, MD
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Madrid, Madrid, España, 28040
- Hospital Clínico San Carlos
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Contacto:
- Constanza Ciriza de los Ríos, MD, PhD
- Número de teléfono: +34 91 330 30 00
- Correo electrónico: constanzacarpa@gmail.com
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Investigador principal:
- Constanza Ciriza de los Ríos, MD, PhD
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Investigador principal:
- Ana Zatarain Valles, MD
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Madrid, Madrid, España
- Hospital de La Princesa
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Contacto:
- Cecilio Santander Vaquero, MD, PhD
- Número de teléfono: +34 915 20 22 00
- Correo electrónico: ceciliosantander@hotmail.com
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Investigador principal:
- Cecilio Santander Vaquero, MD, PhD
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Majadahonda
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Madrid, Majadahonda, España, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Contacto:
- Rosalia González-Miyar, MD
- Número de teléfono: +34 91 191 60 00.
- Correo electrónico: rosaliagomi@gmail.com
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Investigador principal:
- Rosalia González-Miyar, MD
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Pamplona
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Pamplona, Pamplona, España, 31008
- Hospital Universitario de Navarra
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Contacto:
- Fermin Estremera-Arévalo, MD, PhD
- Número de teléfono: +34 848 42 22 22
- Correo electrónico: festremera15@gmail.com
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Investigador principal:
- Fermin Estremera-Arévalo, MD, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
1
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: 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. |
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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants With Clinical Response at 3 Months
Periodo de tiempo: 3 months after botulinum toxin administration or, for participants initially managed conservatively, 3 months after the index endoscopy.
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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.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Response During Follow-up
Periodo de tiempo: Months 1, 6, and 12.
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Proportion of participants with at least a 50% reduction from baseline in BEDQ total score. |
Months 1, 6, and 12.
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Change From Baseline in BEDQ Score
Periodo de tiempo: Baseline and months 1, 3, 6, and 12.
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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.
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Change From Baseline in Eckardt Score
Periodo de tiempo: Baseline and months 1, 3, 6, and 12.
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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.
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Sustained Clinical Response
Periodo de tiempo: Months 3 through 12.
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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.
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Dysphagia Recurrence After Clinical Response
Periodo de tiempo: From the first documented response through month 12.
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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.
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Proportion of Participants Receiving Definitive EGJ-Directed Treatment
Periodo de tiempo: Through month 12.
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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.
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Adverse Events Related to Procedures or Treatment
Periodo de tiempo: From the index endoscopy through month 12.
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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.
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Agreement Between Local and Central EndoFLIP Classification
Periodo de tiempo: Index endoscopy, with subsequent central review of the same recording.
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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.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Jorge Luis Núñez-Pizarro, MD, Hospital Clinic of Barcelona
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Carlson DA, Schauer JM, Kou W, Kahrilas PJ, Pandolfino JE. Functional Lumen Imaging Probe Panometry Helps Identify Clinically Relevant Esophagogastric Junction Outflow Obstruction per Chicago Classification v4.0. Am J Gastroenterol. 2023 Jan 1;118(1):77-86. doi: 10.14309/ajg.0000000000001980. Epub 2022 Aug 23.
- Yadlapati R, Kahrilas PJ, Fox MR, Bredenoord AJ, Prakash Gyawali C, Roman S, Babaei A, Mittal RK, Rommel N, Savarino E, Sifrim D, Smout A, Vaezi MF, Zerbib F, Akiyama J, Bhatia S, Bor S, Carlson DA, Chen JW, Cisternas D, Cock C, Coss-Adame E, de Bortoli N, Defilippi C, Fass R, Ghoshal UC, Gonlachanvit S, Hani A, Hebbard GS, Wook Jung K, Katz P, Katzka DA, Khan A, Kohn GP, Lazarescu A, Lengliner J, Mittal SK, Omari T, Park MI, Penagini R, Pohl D, Richter JE, Serra J, Sweis R, Tack J, Tatum RP, Tutuian R, Vela MF, Wong RK, Wu JC, Xiao Y, Pandolfino JE. Esophageal motility disorders on high-resolution manometry: Chicago classification version 4.0(c). Neurogastroenterol Motil. 2021 Jan;33(1):e14058. doi: 10.1111/nmo.14058.
- Fass OZ, Pandolfino JE, Schauer JM, Ganesh N, Farina DA, Lat A, Goudie E, Kelahan LC, Carlson DA. Diagnostic Accuracy of Timed Barium Esophagram for Achalasia. Gastroenterology. 2025 Jul;169(1):63-72. doi: 10.1053/j.gastro.2025.02.013. Epub 2025 Feb 26.
- Cisternas D, Taft T, Carlson DA, Glasinovic E, Monrroy H, Rey P, Hani A, Ardila-Hani A, Leguizamo AM, Bilder C, Ditaranto A, Varela A, Agotegaray J, Remes-Troche JM, Ruiz de Leon A, Perez de la Serna J, Marin I, Serra J. Validation and psychometric evaluation of the Spanish version of Brief Esophageal Dysphagia Questionnaire (BEDQ): Results of a multicentric study. Neurogastroenterol Motil. 2021 Apr;33(4):e14025. doi: 10.1111/nmo.14025. Epub 2020 Nov 9.
- Biermann M, Obineme C, Godiers M, Kundu S, Jain AS. The functional lumen imaging probe contractile response pattern is the best predictor of botulinum toxin response in esophagogastric junction outflow obstruction. Neurogastroenterol Motil. 2024 Sep;36(9):e14859. doi: 10.1111/nmo.14859. Epub 2024 Jul 10.
- Lee GW, Kim SJ, Choi CW, Park SB, Ryu DG, Kim WJ. Clinical outcomes of Botox injection according to subgroups of esophagogastric junction outflow obstruction: A single institutional retrospective analysis. Medicine (Baltimore). 2025 Jun 20;104(25):e43005. doi: 10.1097/MD.0000000000043005.
- Nguyen AD, Carlson DA, Patel A, Gyawali CP. AGA Clinical Practice Update on Incorporating Functional Lumen Imaging Probe Into Esophageal Clinical Practice: Expert Review. Gastroenterology. 2025 Sep;169(4):726-736.e1. doi: 10.1053/j.gastro.2025.05.011. Epub 2025 Jul 18.
- Beveridge CA, Triggs JR, Thanawala SU, Ahuja NK, Falk GW, Benitez AJ, Lynch KL. Can FLIP guide therapy in idiopathic esophagogastric junction outflow obstruction? Dis Esophagus. 2022 Apr 19;35(4):doab077. doi: 10.1093/dote/doab077.
- Carlson DA, Pandolfino JE, Yadlapati R, Vela MF, Spechler SJ, Schnoll-Sussman FH, Lynch K, Lazarescu A, Khan A, Katz P, Jain AS, Gyawali CP, Gupta M, Garza JM, Fass R, Clarke JO, Chokshi RV, Chen J, Ravi K, Chan WW, Sultan S, Konda VJA. A Standardized Approach to Performing and Interpreting Functional Lumen Imaging Probe Panometry for Esophageal Motility Disorders: The Dallas Consensus. Gastroenterology. 2025 Jun;168(6):1114-1127.e5. doi: 10.1053/j.gastro.2025.01.234. Epub 2025 Feb 4.
- Leopold AR, Jalalian A, Thaker P, Wellington J, Papademetriou M, Xie G. Major mixed motility disorders: An important subset of esophagogastric junction outflow obstruction. Neurogastroenterol Motil. 2023 Jul;35(7):e14555. doi: 10.1111/nmo.14555. Epub 2023 Feb 27.
- Sanagapalli S, McGuire J, Leong RW, Patel K, Raeburn A, Abdul-Razakq H, Plumb A, Banks M, Haidry R, Lovat L, Sehgal V, Graham D, Sami SS, Sweis R. The Clinical Relevance of Manometric Esophagogastric Junction Outflow Obstruction Can Be Determined Using Rapid Drink Challenge and Solid Swallows. Am J Gastroenterol. 2021 Feb 1;116(2):280-288. doi: 10.14309/ajg.0000000000000988.
- Reddy CA, Ellison A, Nguyen AD, Podgaetz E, Souza RF, Konda VJA, Spechler SJ. Botulinum toxin injection of the lower esophageal sphincter to identify achalasia-variant esophagogastric junction outflow obstruction. Dis Esophagus. 2025 Jan 7;38(1):doae082. doi: 10.1093/dote/doae082.
- Jacobs CC, Perbtani Y, Yang D, Al-Haddad MA, Obaitan I, Othman M, Groth S, Sethi A, Agarunov E, Repici A, Maselli R, Galtieri A, Moremen J, Jenkins HN, Samarasena JB, Chang KJ, Draganov PV. Per-Oral Endoscopic Myotomy for Esophagogastric Junction Outflow Obstruction: A Multicenter Pilot Study. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1717-1719.e1. doi: 10.1016/j.cgh.2020.08.048. Epub 2020 Aug 22.
- Sarici IS, Eriksson S, Abu-Nuwar MR, Kuzy J, Gardner M, Zheng P, Jobe B, Ayazi S. Peroral Endoscopic Myotomy (POEM) and Laparoscopic Heller Myotomy with Dor Fundoplication for Esophagogastric Junction Outflow Obstruction (EGJOO): a Comparison of Outcomes and Impact on Physiology. J Gastrointest Surg. 2023 Nov;27(11):2684-2693. doi: 10.1007/s11605-023-05844-0. Epub 2023 Oct 17.
- Khan A, Yadlapati R, Gonlachanvit S, Katzka DA, Park MI, Vaezi M, Vela M, Pandolfino J. Chicago Classification update (version 4.0): Technical review on diagnostic criteria for achalasia. Neurogastroenterol Motil. 2021 Jul;33(7):e14182. doi: 10.1111/nmo.14182. Epub 2021 Jun 30.
- Visaggi P, Ghisa M, Del Corso G, Baiano Svizzero F, Mariani L, Tolone S, Frazzoni M, Buda A, Bellini M, Savarino V, Penagini R, Gyawali CP, Savarino EV, de Bortoli N. Chicago classification v4.0 protocol improves specificity and accuracy of diagnosis of oesophagogastric junction outflow obstruction. Aliment Pharmacol Ther. 2022 Aug;56(4):606-613. doi: 10.1111/apt.17101. Epub 2022 Jun 25.
- Carlson DA, Yadlapati R, Pandolfino JE. The Tailored Approach to Manometric Esophagogastric Junction Outflow Obstruction: Treat the Clinical Diagnosis, Not the Manometry Pattern. Am J Gastroenterol. 2023 Jan 1;118(1):5-9. doi: 10.14309/ajg.0000000000001938. Epub 2022 Aug 12. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
7 de diciembre de 2026
Finalización primaria (Estimado)
Finalización primaria
6 de marzo de 2029
Finalización del estudio (Estimado)
Finalización del estudio
6 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
4 de noviembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
4 de noviembre de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
10 de noviembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
10 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
4 de noviembre de 2026
Última verificación
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades esofágicas
- Enfermedades Otorrinolaringológicas
- Enfermedades faríngeas
- Trastornos de la deglución
- Trastornos de la motilidad esofágica
- Aminoácidos, péptidos y proteínas
- Proteínas
- Factores biológicos
- Hidrolasas
- Enzimas
- Enzimas y coenzimas
- Toxinas botulínicas
- Metaloendopeptidasas
- Endopeptidasas
- Hidrolasas peptídicas
- Metaloproteasas
- Proteínas bacterianas
- Toxinas bacterianas
- Toxinas, biológicas
- Toxinas botulínicas tipo A
Otros números de identificación del estudio
Otros números de identificación del estudio
- HCB/2026/1095
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .