NCT02703376

Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Nagasaki University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Esophageal Anastomotic Stricture

Interventions

Type	Name	Description
DRUG	Oral Prednisone	Intakes of Oral Prednisone for 12 weeks after balloon dilations

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-03-01
• Completion: 2019-10-01
• First posted: 2016-03-09
• Last updated: 2016-03-09

Locations

1 site across 1 country: Japan