Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Anastomotic Stricture||Drug: Oral Prednisone||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification [ Time Frame: for 12 weeks after the intervention ]
- 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
- Incidence of treatment discontinuations, modifications, and interruptions due to adverse events [ Time Frame: for 12 weeks after the intervention ]
- Rate of re-strictures at 85 postoperative days [ Time Frame: for 12 weeks after the intervention ]
- Number of participants with endoscopic classification of strictures before intervention [ Time Frame: before the intervention ]
- Dysphagia score [ Time Frame: for 12 weeks after the intervention ]
- Session of the dilatation [ Time Frame: for 12 weeks after the intervention ]
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
|Contact: Kobayashi Shinichiro, M.D.||+email@example.com|
|Contact: Kobayashi Shinichirofirstname.lastname@example.org|
|Nagasaki, Japan, 852-8501|
|Contact: Kobayashi Shinichiro, M.D. +81958197316 email@example.com|
|Study Director:||Kobayashi Shinichiro||Department of Surgery Nagasaki University Graduate School of Biomedical Sciences|