Clinical Trial: Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Nagasaki University

Current Primary Outcome:

  • Number 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 [ Time Frame: for 12 weeks after the intervention ]
    physical conditions, clinical laboratory abnormalities, and ECG abnormalities
  • Incidence of treatment discontinuations, modifications, and interruptions due to adverse events [ Time Frame: for 12 weeks after the intervention ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Nagasaki University

Dates:
Date Received: January 18, 2016
Date Started: January 2016
Date Completion: October 2019
Last Updated: March 3, 2016
Last Verified: March 2016