Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

March 3, 2016 updated by: Kobayashi Shinichiro, Nagasaki University
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 Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients after esophageal surgery
Oral Prednisone for 12 weeks
Drug: Oral Prednisone
Intakes of Oral Prednisone for 12 weeks after balloon dilations
Other Names:
  • prednisolone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagasaki University

Investigators

  • Study Director: Kobayashi Shinichiro, Department of Surgery Nagasaki University Graduate School of Biomedical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NagasakiU2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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