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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
8
Intakes of Oral Prednisone for 12 weeks after balloon dilations
Nagasaki University
Nagasaki, Nagasaki, Japan
RECRUITINGNumber of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification
Time frame: for 12 weeks after the intervention
Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0
physical conditions, clinical laboratory abnormalities, and ECG abnormalities
Time frame: for 12 weeks after the intervention
Incidence of treatment discontinuations, modifications, and interruptions due to adverse events
Time frame: for 12 weeks after the intervention
Rate of re-strictures at 85 postoperative days
Time frame: for 12 weeks after the intervention
Number of participants with endoscopic classification of strictures before intervention
Time frame: before the intervention
Dysphagia score
Time frame: for 12 weeks after the intervention
Session of the dilatation
Time frame: for 12 weeks after the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.