Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Conditions
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Esophageal Anastomotic Stricture

Intervention / Treatment
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* Drug: Oral Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who develop the severe esophageal strictures from 28 days after esophageal surgery Exclusion Criteria: Pulmonary and cardiac disorders Liver and renal dysfunctions Allergic Pregnancy infectious disease Unsuitable condition

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients after esophageal surgery<br>Oral Prednisone for 12 weeks | Drug: Oral Prednisone<br>* Intakes of Oral Prednisone for 12 weeks after balloon dilations<br>* Other names: prednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification |  | 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 | for 12 weeks after the intervention | 
| Incidence of treatment discontinuations, modifications, and interruptions due to adverse events |  | for 12 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-strictures at 85 postoperative days |  | for 12 weeks after the intervention | 
| Number of participants with endoscopic classification of strictures before intervention |  | before the intervention | 
| Dysphagia score |  | for 12 weeks after the intervention | 
| Session of the dilatation |  | for 12 weeks after the intervention |