Clinical Trial Summary
Benign esophageal strictures are frequently seen in endoscopic practice and are caused by a
variety of esophageal disorders, including peptic, radiotherapy-induced and caustic injuries,
Schatzki ring, eosinophilic esophagitis (EoE), and strictures after surgical resection
(anastomotic) or endoscopic resection (endoscopic mucosal resection-EMR- and endoscopic
submucosal dissection-ESD), and ablative therapies (Radiofrequency, Cryotherapy and
Argon-plasma coagulation).
Endoscopic dilation is the first treatment step for benign esophageal strictures. Two types
of dilators are available, namely, through-the-scope balloon dilators, with or without a
guidewire, and wire-guided bougie dilators. Bougie dilators are used for simple strictures
and for strictures in the proximal esophagus, especially anastomotic strictures. Bougie
dilators exert a combined radial and longitudinal force, which may increase the risk of
perforation. Bougie dilators allow, however, sensing the degree of resistance during
dilation, and thereby help determining increasing bougie sizes during next-step dilations.
Through the-scope balloon dilators are preferred for complex strictures. Balloons dilators
allow direct visualization and control of the radially applied dilation force. In literature,
both dilation techniques appear to be equally effective and safe in the management of
esophageal strictures, showing no differences in terms of risks of AEs About 30 years ago,
the "rule of three" has been published. This rule dictated the extent of dilation during any
endoscopic session (i.e., no more than three dilators successively larger than the first
dilator to meet resistance were passed) and has been used by endoscopists to reduce the risk
of perforation. However, the safety of the "rule of three" has never been demonstrated.
Moreover, a recent study suggests that more than three dilation steps per session may be
considered for esophageal strictures, with the exception of malignant strictures. The EsoFLIP
(Medtronic Inc., Shoreview, MN, USA) is a novel dilation balloon that provides real-time,
objective visualization and monitoring of therapeutic dilation. EsoFLIP utilizes
high-resolution impedance planimetry to provide real-time measurements (diameter and
cross-sectional area) of the stenotic area before, during, and at the end of the dilation
without the need of fluoroscopy.
In 2013, technical feasibility and safety of the EsoFLIP in esophago-gastric junction (EGJ)
dilation have been demonstrated on porcine models. In a small first pilot study, the
technical feasibility of the EsoFLIP device in 10 patients with achalasia has been
demonstrated. A second study reported short-term efficacy, both objective (improvement in
barium column) and subjective (improvement in Eckardt score), in 28 patients managed using
the FLIP hydraulic balloon dilator. Very limited data are currently available in the
literature on the use of EsoFLIP in benign esophageal strictures dilation. Potential
advantages of the use of EsoFLIP are dilation without fluoroscopy and associated radiation,
control of dilation sizes to generate the desired dilation effect and assessment of stricture
size and the response to dilatation immediately following dilation.
In a small single centre retrospective study on 19 paediatric patients, use of EsoFLIP
hydraulic dilation was safe and provided a larger diameter increase compared with standard
balloon dilation, but this was not statistically significant likely because of the small
cohort size. The study also suggested that procedure time and fluoroscopy time were shorter
in the EsoFLIP cases when compared to other traditional dilation methods. Esophageal dilation
using EsoFLIP may yield a larger diameter change increasing the interval between a dilatation
procedure and the following one and may potentially reduce procedure time when compared to
traditional balloon dilation.
There is currently no published prospective study about dilation with EsoFLIP in adult
patients affected by benign esophageal strictures. The endoluminal functional lumen imaging
probe, EndoFLIP™ (Medtronic, Minneapolis, MN, USA) (FLIP), is a tool that utilizes impedance
planimetry, a technique for performing balloon distention in the alimentary track, to obtain
dynamic measurements of any sphincters including the diameter, cross-sectional area (CSA),
and distensibility index (DI). Diseases where Endo-FLIP has been employed include esophageal
stenosis, reflux esophagitis, eosinophilic esophagitis, gastroparesis, anal sphincter
disease, achalasia, and it has also been used in peroral endoscopic myotomy.
