Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02703376

Enrollment

Registered

2016-03-09

Start date

2016-01-31

Completion date

2019-10-31

Last updated

2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Anastomotic Stricture

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.

Interventions

DRUGOral Prednisone

Intakes of Oral Prednisone for 12 weeks after balloon dilations

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
Incidence of treatment discontinuations, modifications, and interruptions due to adverse events	for 12 weeks after the intervention	—

Secondary

Measure	Time frame
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
Dysphagia score	for 12 weeks after the intervention
Session of the dilatation	for 12 weeks after the intervention

Countries

Japan

Contacts

Primary ContactKobayashi Shinichiro, M.D.

skobayashi1980@gmail.com+81958197316

Backup ContactKobayashi Shinichiro