NCT02703376

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

3.2 years

First QC Date

January 18, 2016

Last Update Submit

March 3, 2016

Conditions

Esophageal Anastomotic Stricture

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    for 12 weeks after the intervention

Secondary Outcomes (4)

  • 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

Study Arms (1)

Patients after esophageal surgery

OTHER

Oral Prednisone for 12 weeks

Drug: Oral Prednisone

Interventions

Oral PrednisoneDRUG

Intakes of Oral Prednisone for 12 weeks after balloon dilations

Also known as: prednisolone
Patients after esophageal surgery

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who develop the severe esophageal strictures from 28 days after esophageal surgery

You may not qualify if:

  • Pulmonary and cardiac disorders
  • Liver and renal dysfunctions
  • Allergic
  • Pregnancy
  • infectious disease
  • Unsuitable condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagasaki University

Nagasaki, Nagasaki, 852-8501, Japan

RECRUITING

Related Publications (2)

  • Yamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14.

    PMID: 21492854BACKGROUND

  • Kobayashi S, Kanai N, Ohki T, Takagi R, Yamaguchi N, Isomoto H, Kasai Y, Hosoi T, Nakao K, Eguchi S, Yamamoto M, Yamato M, Okano T. Prevention of esophageal strictures after endoscopic submucosal dissection. World J Gastroenterol. 2014 Nov 7;20(41):15098-109. doi: 10.3748/wjg.v20.i41.15098.

    PMID: 25386058BACKGROUND

MeSH Terms

Interventions

PrednisonePrednisolone

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriols

Study Officials

  • Kobayashi Shinichiro

    Department of Surgery Nagasaki University Graduate School of Biomedical Sciences

    STUDY DIRECTOR

Central Study Contacts

Kobayashi Shinichiro, M.D.

CONTACT

+81958197316skobayashi1980@gmail.com

Kobayashi Shinichiro

CONTACT

+81958197316skobayashi1980@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 18, 2016

First Posted

March 9, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2019

Study Completion

October 1, 2019

Last Updated

March 9, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)