Esophageal Anastomotic Stricture Clinical Trial
Official title:
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
This study is safety and proof-of-concept study for oral prednisolone in the treatment of esophageal stricture after esophageal surgery. The patients who develop the severe esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes are Safety and Success rate of this treatment.
Esophageal strictures are common complications after surgery and aggressive endoscopic
submucosal dissection (ESD) for early-stage esophageal cancer and adenocarcinoma. However,
patients, who develop esophageal strictures after extensive operations, usually develop
refractory strictures. Although there are several treatments for refractory strictures,
their utility is limited.
Yamaguchi and colleagues have developed new treatments using oral prednisolone. They have
shown the safety and potential efficacy to prevent esophageal strictures after ESD. However,
the efficacy and safety of oral prednisolone is not evaluated to esophageal stricture after
esophageal surgery.
This study is safety and proof-of-concept study for oral prednisolone in the treatment of
esophageal stricture after esophageal surgery. The patients who develop the severe
esophageal strictures from 28 days after esophageal surgery are included. Primary outcomes
are Safety and Success rate of this treatment.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention