Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

NCT ID: NCT02703376

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Esophageal Anastomotic Stricture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients after esophageal surgery

Oral Prednisone for 12 weeks

Group Type OTHER

Oral Prednisone

Intervention Type DRUG

Intakes of Oral Prednisone for 12 weeks after balloon dilations

Interventions

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Oral Prednisone

Intakes of Oral Prednisone for 12 weeks after balloon dilations

Intervention Type DRUG

Other Intervention Names

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prednisolone

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagasaki University

OTHER

Sponsor Role lead

Responsible Party

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Kobayashi Shinichiro

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kobayashi Shinichiro

Role: STUDY_DIRECTOR

Department of Surgery Nagasaki University Graduate School of Biomedical Sciences

Locations

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Nagasaki University

Nagasaki, Nagasaki, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Kobayashi Shinichiro, M.D.

Role: CONTACT

+81958197316

Kobayashi Shinichiro

Role: CONTACT

+81958197316

Facility Contacts

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Kobayashi Shinichiro, M.D.

Role: primary

+81958197316

References

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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.

Reference Type BACKGROUND
PMID: 21492854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25386058 (View on PubMed)

Other Identifiers

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NagasakiU2

Identifier Type: -

Identifier Source: org_study_id

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