Measuring Normal Esophageal Flexibility in Children Using EndoFLIP (EndoFLIP)
Prospective Measurement of Normative Esophageal Distensibility Using EndoFLIP in Asymptomatic Children
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Descrição detalhada
The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared device that measures the size, pressure, and flexibility (distensibility) of the esophagus. In adults, EndoFLIP measurements are routinely used to evaluate esophageal motility disorders such as achalasia. However, normal reference values for children have not been established, and pediatric interpretation currently relies largely on adult data.
The purpose of this prospective, single-center observational study is to generate preliminary normative pediatric EndoFLIP measurements. One hundred children between 5 and younger than 18 years of age who are undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia will be enrolled. Eligible participants must have no history of esophageal disease or surgery and no symptoms suggestive of upper gastrointestinal disease.
Immediately before the scheduled colonoscopy and motility catheter placement, an EndoFLIP catheter will be inserted through the mouth and positioned across the lower esophageal sphincter. Measurements of esophageal diameter, cross-sectional area, pressure, compliance, and distensibility index will be obtained at standardized balloon fill volumes (20-60 mL). The EndoFLIP assessment requires approximately 3-5 minutes and does not require an upper endoscopy or any additional anesthesia. After the measurements are completed, the catheter is removed and the planned clinical procedure proceeds as scheduled. No additional study visits or follow-up are required.
The primary objective is to establish preliminary normative pediatric values for esophageal distensibility and related biomechanical parameters. Secondary analyses will evaluate associations between EndoFLIP measurements and participant age, height, weight, and body mass index. These data are intended to improve interpretation of pediatric EndoFLIP studies and support future research and clinical care for children with esophageal disorders.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
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- Filho
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Descrição
Inclusion Criteria:
- Age 5 to <18 years
- Scheduled to undergo clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia
- No upper gastrointestinal symptoms (including dysphagia, recurrent vomiting, gastroesophageal reflux, or odynophagia)
- No history of esophageal disease or esophageal surgery
- Parent/guardian consent and participant assent, when applicable
Exclusion Criteria:
- Known or suspected esophageal pathology
- Prior esophageal surgery or instrumentation
- Anatomic upper gastrointestinal abnormalities
- Contraindication to anesthesia or EndoFLIP catheter placement
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Asymptomatic Children Undergoing EndoFLIP Assessment
Children 5 to younger than 18 years of age undergoing clinically indicated colonoscopy with colonic motility catheter placement under general anesthesia who have no history or symptoms of esophageal disease.
Participants undergo a single 3-5 minute EndoFLIP assessment before the scheduled procedure to measure esophageal distensibility index, diameter, cross-sectional area, compliance, and pressure for development of preliminary normative pediatric reference values.
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The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-cleared impedance planimetry device used to measure esophageal diameter, cross-sectional area, intraballoon pressure, distensibility index, and compliance.
In this study, the EndoFLIP catheter is inserted orally during general anesthesia immediately before clinically indicated colonoscopy with colonic motility catheter placement.
Measurements are obtained over approximately 3-5 minutes at standardized balloon fill volumes of 20-60 mL, after which the catheter is removed and the planned clinical procedure proceeds.
The EndoFLIP assessment is performed solely for research purposes to establish preliminary normative pediatric esophageal biomechanical reference values.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Esophageal Distensibility
Prazo: During the procedure (approximately 3-5 minutes)
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Esophageal distensibility index measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Esophageal Diameter
Prazo: During the procedure (approximately 3-5 minutes)
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Esophageal diameter measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Esophageal Cross-sectional Area
Prazo: During the procedure (approximately 3-5 minutes)
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Esophageal cross-sectional area measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Esophageal Compliance
Prazo: During the procedure (approximately 3-5 minutes)
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Esophageal compliance measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Intraballoon Pressure
Prazo: During the procedure (approximately 3-5 minutes)
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Intraballoon pressure measured using the Endoluminal Functional Lumen Imaging Probe (EndoFLIP) at standardized balloon fill volumes of 20, 30, 40, 50, and 60 mL.
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During the procedure (approximately 3-5 minutes)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Outros números de identificação do estudo
- 28226
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