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Trial record 2 of 5 for:    "Esophageal Disease" | "Prednisone"

Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery

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ClinicalTrials.gov Identifier: NCT02703376
Recruitment Status : Unknown
Verified March 2016 by Kobayashi Shinichiro, Nagasaki University.
Recruitment status was:  Recruiting
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Kobayashi Shinichiro, Nagasaki University

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.

Condition or disease Intervention/treatment Phase
Esophageal Anastomotic Stricture Drug: Oral Prednisone Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Patients after esophageal surgery
Oral Prednisone for 12 weeks
Drug: Oral Prednisone
Intakes of Oral Prednisone for 12 weeks after balloon dilations
Other Name: prednisolone




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification [ Time Frame: for 12 weeks after the intervention ]
  2. Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0 [ Time Frame: for 12 weeks after the intervention ]
    physical conditions, clinical laboratory abnormalities, and ECG abnormalities

  3. Incidence of treatment discontinuations, modifications, and interruptions due to adverse events [ Time Frame: for 12 weeks after the intervention ]

Secondary Outcome Measures :
  1. Rate of re-strictures at 85 postoperative days [ Time Frame: for 12 weeks after the intervention ]
  2. Number of participants with endoscopic classification of strictures before intervention [ Time Frame: before the intervention ]
  3. Dysphagia score [ Time Frame: for 12 weeks after the intervention ]
  4. Session of the dilatation [ Time Frame: for 12 weeks after the intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703376


Contacts
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Contact: Kobayashi Shinichiro, M.D. +81958197316 skobayashi1980@gmail.com
Contact: Kobayashi Shinichiro +81958197316 skobayashi1980@gmail.com

Locations
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Japan
Nagasaki University Recruiting
Nagasaki, Japan, 852-8501
Contact: Kobayashi Shinichiro, M.D.    +81958197316    shinichirokobayashi@nagasaki-u.ac.jp   
Sponsors and Collaborators
Nagasaki University
Investigators
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Study Director: Kobayashi Shinichiro Department of Surgery Nagasaki University Graduate School of Biomedical Sciences

Publications:
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Responsible Party: Kobayashi Shinichiro, Assistant professor, Nagasaki University
ClinicalTrials.gov Identifier: NCT02703376     History of Changes
Other Study ID Numbers: NagasakiU2
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Diseases
Prednisone
Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents