Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Nagasaki University

Status and phase: Unknown; Phase 1

Conditions: Esophageal Anastomotic Stricture

Treatments: Drug: Oral Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02703376

NagasakiU2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Patients after esophageal surgery

Other group

Description:

Oral Prednisone for 12 weeks

Treatment:

Drug: Oral Prednisone