Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
NCT ID: NCT02703376
Last Updated: 2016-03-09
Study Results
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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UNKNOWN
PHASE1
8 participants
INTERVENTIONAL
2016-01-31
2019-10-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Patients after esophageal surgery
Oral Prednisone for 12 weeks
Oral Prednisone
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Liver and renal dysfunctions
* Allergic
* Pregnancy
* infectious disease
* Unsuitable condition
20 Years
85 Years
ALL
No
Sponsors
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Nagasaki University
OTHER
Responsible Party
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Kobayashi Shinichiro
Assistant professor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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NagasakiU2
Identifier Type: -
Identifier Source: org_study_id
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