Endoluminal Functional Lumen Imaging Probe Is Safe in Children Under Five Years Old

Abstract

Background:Endoluminal functional lumen imaging probe (EndoFLIP) is a minimally invasive, novel device that uses high-resolution impedance planimetry to measure important parameters of the gastrointestinal lumen that aid in the diagnosis of esophageal disorders. EndoFLiP is approved by the US Food and Drug Administration (FDA) for children 5 years and older. We sought to compare its safety and luminal characteristics between children under 5 years of age with children 5 years and older.Methods:A single-center retrospective review was performed to identify all patients < 21 years of age who underwent esophagogastroduodenoscopy (EGD) with EndoFLIP between October 2017 and November 2020. Results: Sixty-seven EGDs with EndoFLIP were performed in 56 patients, including 14 that were done in children < 5 years and 53 in children ≥5years. The median age in the < 5-year group was 1.7years (interquartile range [IQR], 0.9–4.4) and the youngest patient was 1 month old. The median age in ≥5-year group was 14.3 years (IQR, 8.2–16.2). Median procedure times were similar (32 minutes [IQR, 25–48] for the < 5-year group; 28 minutes [IQR, 20–33] for ≥5-year group; P = 0.08). There were no adverse events or unplanned hospitalizations in either group. At 30 mL inflation, the pressure of the lower esophageal sphincter (LES) was statistically different between the 2 groups (P = 0.02).Conclusion:EndoFLIP appears to be safe for use in our small cohort of children < 5 years of age and may be an important tool in the management of esophageal disorders in this age group. There was no difference in procedure time between our 2 age groups and there were no procedure-related complications.

A Child with an Esophageal Web Treated with Functional Lumen Imaging Probe

“…Additionally, the patient’s initial stricture size prevented the use of EndoFLIP and EsoFLIP. This work further supports previously published data that highlights the safety and utility of FLIP devices in the treatment of pediatric esophageal strictures ( 3 ). EndoFLIP allows for direct luminal assessment in real time removing the need to rely on fluoroscopic images.…”

“…Additionally, the contraction data generated with the EndoFLIP topography module are based on secondary peristalsis, which is different from the methodology of high-resolution manometry (HRM) ( 5 ). However, secondary peristalsis may provide unique advantages, enabling visualization of contractility patterns not seen with HRM ( 3 ). Moreover, a recent study by Rosen et al ( 6 ) that compared HRM and FLIP concluded that the two modalities were complementary.…”

“…Endoluminal functional lumen imaging probe (EndoFLIP; Medtronic, Minneapolis, MN) is a novel balloon device that uses impedance planimetry to produce real-time quantitative data about the gastrointestinal (GI) lumen, providing important luminal parameters (ie, diameter, cross-sectional area (CSA), compliance, pressure, and distensibility index [DI]) ( 3 ). EndoFLIP can be completed in less than 5 minutes during a sedated esophagogastroduodenoscopy (EGD), and can be used to guide endoscopic therapies by providing luminal information before and after treatment.…”

“…Although EndoFLIP is used for diagnostic evaluation, EsoFLIP (Medtronic) is a therapeutic variant that can also dilate a luminal stricture while also providing the diameter and cross-sectional area in real-time. Although EndoFLIP is currently Food and Drug Administration (FDA) approved in children greater than 5 years of age, Hoskins et al ( 3 ) showed that it is also safe when used in children less than 5 years of age. The clinical indication of EndoFLIP is rapidly expanding, especially within the pediatric population.…”

Measurement of Stricture Dimensions Using a Visual Comparative Estimation Method With Biopsy Forceps During Endoscopy

“…An important benefit of the biopsy forceps method for estimating stricture dimensions is its use of an inexpensive, widely available visual reference tool that does not require additional expensive equipment or training such as endoluminal functional lumen imaging probe (EndoFLIP) or EsoFLIP (Medtronic Inc, Shoreview, MN). There is currently no standard protocol for End-oFLIP or EsoFLIP use in children and is not U.S. Food and Drug Administration approved for use in children younger than 5 years, though there is limited emerging experience to suggest these functional lumen imaging probe technologies are likely safe and can afford the ability to reduce radiation exposure to patients in some settings (9). As per the manufacturer, the use of FLIP catheters is currently not suitable for treatment of strictures smaller than 8 mm, limiting its use in children with very tight strictures.…”