Esophageal Stenosis Clinical Trial
Official title:
Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection
Endoscopic resection of superficial esophageal neoplasms is already a reality and presents
important advantages when compared to esophagectomy as fewer complications and better quality
of life. However, extensive resections can lead to difficult-to-manage stenoses. There are
several therapies available in order to prevent this stenosis but, to date, there is no
definition of the gold standard.
The objective of this study was to compare the use of intralesional steroid injection versus
oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate,
number of dilations to resolve the stenosis and complications.
Endoscopic resection of superficial esophageal neoplasms is widely used as an alternative to
esophagectomy, since it is less invasive, besides presenting good clinical results. Compared
with esophagectomy, patients submitted to endoscopic resection present shorter
hospitalization time, lower incidence of complications and better quality of life in the long
term.
However, repair of esophageal ulcer, caused by endoscopic resection, which occupies three
quarters or more of the circumference of the organ, can result in the formation of stenosis.
In the past, there was no consensus on the use of preventive therapies for esophageal
stenosis after extensive ESD. However, Oliveira et al recently demonstrated through
systematic review and meta-analysis that the use of these therapies reduces the rate of
stenosis (40% on average), decreased the number of dilations to resolve the stenosis (8
sessions less ), Without altering the number of complications.
Theoretically, corticosteroids are the most appropriate choice due to their mechanism of
action, modulating wound healing by preventing inflammation, by reducing prolyl hydroxylase,
which helps reduce collagen production.
However, treatment with corticosteroids, especially at high oral doses, can cause several
adverse effects, such as immunosuppression, diabetes, psychiatric disorders, osteoporosis,
optic lesion and peptic ulcer. Thus, the use of local corticosteroid injection could minimize
these side effects. However, local injection implies risks of bleeding and perforation, and
is of limited use in patients receiving anticoagulant or antiplatelet therapy.
The objective of this study was to compare the local corticosteroid injection and the use of
oral corticosteroids to prevent stenosis after extensive submucosal endoscopic resection of
superficial esophageal carcinoma, in relation to the stenosis rate, number of dilations
necessary to resolve the stenosis and frequency of complications.
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