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Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Primary Purpose

Esophageal Anastomotic Stricture

Status

Unknown status

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Oral Prednisone

About this trial

This is an interventional prevention trial for Esophageal Anastomotic Stricture

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Nagasaki UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients after esophageal surgery

Arm Description

Oral Prednisone for 12 weeks

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification

Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0

physical conditions, clinical laboratory abnormalities, and ECG abnormalities

Incidence of treatment discontinuations, modifications, and interruptions due to adverse events

Secondary Outcome Measures

Rate of re-strictures at 85 postoperative days

Number of participants with endoscopic classification of strictures before intervention

Dysphagia score

Session of the dilatation

Full Information

NCT ID

NCT02703376

First Posted

January 18, 2016

Last Updated

March 3, 2016

Sponsor

Nagasaki University

1. Study Identification

Unique Protocol Identification Number

NCT02703376

Brief Title

Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Official Title

Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nagasaki University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Anastomotic Stricture

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients after esophageal surgery

Arm Type

Other

Arm Description

Oral Prednisone for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Oral Prednisone

Other Intervention Name(s)

prednisolone

Intervention Description

Intakes of Oral Prednisone for 12 weeks after balloon dilations

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification

Time Frame

for 12 weeks after the intervention

Title

Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0

Description

physical conditions, clinical laboratory abnormalities, and ECG abnormalities

Time Frame

for 12 weeks after the intervention

Title

Incidence of treatment discontinuations, modifications, and interruptions due to adverse events

Time Frame

for 12 weeks after the intervention

Secondary Outcome Measure Information:

Title

Rate of re-strictures at 85 postoperative days

Time Frame

for 12 weeks after the intervention

Title

Number of participants with endoscopic classification of strictures before intervention

Time Frame

before the intervention

Title

Dysphagia score

Time Frame

for 12 weeks after the intervention

Title

Session of the dilatation

Time Frame

for 12 weeks after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kobayashi Shinichiro, M.D.

Phone

+81958197316

skobayashi1980@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kobayashi Shinichiro

Phone

+81958197316

skobayashi1980@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kobayashi Shinichiro

Organizational Affiliation

Department of Surgery Nagasaki University Graduate School of Biomedical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Nagasaki University

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kobayashi Shinichiro, M.D.

Phone

+81958197316

shinichirokobayashi@nagasaki-u.ac.jp

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21492854

Citation

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.

Results Reference

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PubMed Identifier

25386058

Citation

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.

Results Reference

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Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

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