Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Phase 1

• Conditions: Esophageal Anastomotic Stricture
• Interventions: Drug: Oral Prednisone

• Registration Number: NCT02703376
• Lead Sponsor: Nagasaki University

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-09
• Last Update Posted: 2016-03-09
• Primary Completion: 2019-03
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients after esophageal surgery	Oral Prednisone	Oral Prednisone for 12 weeks

Primary Outcome Measures

Name	Time	Method
Incidence of treatment discontinuations, modifications, and interruptions due to adverse events	for 12 weeks after the intervention
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	for 12 weeks after the intervention	physical conditions, clinical laboratory abnormalities, and ECG abnormalities

Secondary Outcome Measures

Name	Time	Method
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
Session of the dilatation	for 12 weeks after the intervention
Dysphagia score	for 12 weeks after the intervention

Trial Locations

Locations (1)

Nagasaki University; 🇯🇵 Nagasaki, Japan