A clinical practice update, issued by the American Gastroenterological Association (AGA) Institute this March, supports the use of Endoflip® as an innovative method of enhancing the assessment of esophageal function in various diseases, including the management of achalasia, and in assessing disease severity and measuring outcomes in eosinophilic esophagitis. (EoE).
Flip® or functional luminal imaging probe technology is at the core of the Endoflip® imaging system being developed by medical device company Crospon, headquartered in Galway, Ireland. Flip® uses high-resolution impedance during volume-controlled distention to measure luminal geometry and pressure and to assess the mechanical properties of the esophageal wall and opening dynamics of the esophagogastric junction (EGJ) in various esophageal diseases.
It has Food and Drug Administration clearance to guide specialized esophageal surgery and therapy during bariatric procedures as well as to manage various upper gastrointestinal disorders.
“The evolution of esophageal function testing has moved rapidly over the last 10 years along the continuum of manometric technique and bolus transit assessment. Flip® offers an innovative method that enhances the assessment of esophageal function in various diseases, including the management of achalasia. Emerging evidence also supports the clinical relevance of Flip® in assessing disease severity and measuring outcomes in EoE. We recommend that further evaluation is required in the application of Flip® to GERD interventions targeting the EGJ and other foregut disorders.”
Best Practice Advice Statements
Describing the technique and reviewing the potential indications in achalasia, EoE and GERD, the clinical practice update makes the following ‘Best Practice Advice Statements’:
Best Practice Advice Statement 1: Clinicians should not make a diagnosis or treatment decision based on function lumen imaging probe (Flip®) assessment alone;
Best Practice Advice Statement 2: Flip® assessment is a complementary tool to assess esophagogastric junction (EGJ) opening dynamics and the stiffness of the esophageal wall;
Best Practice Advice Statement 3: Utilization should follow distinct protocols and analysis paradigms based on the disease state of interest;
Best Practice Advice Statement 4: Clinicians should not utilize Flip® in routine diagnostic assessments of gastroesophageal reflux disease (GERD);
Best Practice Advice Statement 5: Flip® should not be used to diagnose eosinophilic esophagitis (EoE) but may have a role in severity assessment and therapeutic monitoring.
Comments from Crospon
Commenting on the update, CEO and founder of Crospon John O’Dea welcomed the role of the AGA Institute in updating the gastroenterology profession on new technologies by providing objective clinical assessment in these clinical practice updates.
“We agree that Flip® technology, which is at the core of Crospon’s Endoflip® imaging system, is a complementary tool to assist clinicians in diagnosis, particularly in conjunction with endoscopy,” he said. “While not a diagnostic tool for clinicians in cases of suspected EoE, Endoflip® has a role to play in measuring the response of the esophagus to treatment, particularly where there is a narrowing due to fibro-stenosis and in predicting the risk of food impaction.”
John O’Dea also agreed that more work is needed to progress the use of Flip® in GERD diagnostics, but pointed out that intra-operative use of the technology in GERD surgery is more advanced.
Observing that Flip® technology is currently largely confined to specialized centers, the AG’s clinical practice update noted: “There are limitations in the current analysis techniques because most require post-acquisition processing and specialized programming using MatLAB and are thus not widely available. However, the manufacturer is developing real-time Flip® topography and analytics of maximal diameter in the future software updates.”
John O’Dea again agreed, adding: “We are happy to confirm that these product enhancements are in train, and they, along with additions to our Endoflip® product line later this year, will address a number of these issues, facilitating more widespread adoption beyond specialized centers into general clinical practice.”
Access the AGA Institute’s clinical practice update here.