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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients after esophageal surgery | Other | Oral Prednisone for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Prednisone | Drug | Intakes of Oral Prednisone for 12 weeks after balloon dilations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by Clavien-Dindo Classification | for 12 weeks after the intervention | |
| Incidence of Adverse Events of Grade 3 and Grade 4 of CTCAE v4.0 | physical conditions, clinical laboratory abnormalities, and ECG abnormalities | for 12 weeks after the intervention |
| Incidence of treatment discontinuations, modifications, and interruptions due to adverse events | for 12 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of re-strictures at 85 postoperative days | for 12 weeks after the intervention | |
| Number of participants with endoscopic classification of strictures before intervention | before the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kobayashi Shinichiro, M.D. | Contact | +81958197316 | skobayashi1980@gmail.com | |
| Kobayashi Shinichiro | Contact | +81958197316 | skobayashi1980@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kobayashi Shinichiro | Department of Surgery Nagasaki University Graduate School of Biomedical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagasaki University | Recruiting | Nagasaki | Nagasaki | 852-8501 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21492854 | Background | 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. | |
| 25386058 |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Dysphagia score | for 12 weeks after the intervention |
| Session of the dilatation | for 12 weeks after the intervention |
| Background |
| 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |