A randomized controlled Phase II/III study comparing endoscopic balloon dilation combined with steroid injection versus radial incision and cutting combined with steroid injection for refractory anastomotic stricture after esophagectomy: Japan Clinical Oncology Group Study JCOG1207
| العنوان: | A randomized controlled Phase II/III study comparing endoscopic balloon dilation combined with steroid injection versus radial incision and cutting combined with steroid injection for refractory anastomotic stricture after esophagectomy: Japan Clinical Oncology Group Study JCOG1207 |
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| المؤلفون: | Noboru Hanaoka, Junki Mizusawa, Kohei Takizawa, Manabu Muto, Hiroshi Katayama, Masaki Tanaka, Keiko Minashi, Ikuo Aoyama, Tomonori Yano, Haruhiko Fukuda, Junko Eba, Kozo Kataoka |
| المصدر: | Japanese Journal of Clinical Oncology. 45:385-389 |
| بيانات النشر: | Oxford University Press (OUP), 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Male, Cancer Research, medicine.medical_specialty, Esophageal Neoplasms, medicine.medical_treatment, Constriction, Pathologic, Anastomosis, Endoscopy, Gastrointestinal, Postoperative Complications, Japan, medicine, Clinical endpoint, Humans, Radiology, Nuclear Medicine and imaging, Intraoperative Complications, medicine.diagnostic_test, business.industry, Surrogate endpoint, Standard treatment, General Medicine, medicine.disease, Combined Modality Therapy, Dilatation, Endoscopy, Surgery, Esophagectomy, Oncology, Pneumothorax, Esophageal Stenosis, Balloon dilation, Female, Steroids, Deglutition Disorders, business |
| الوصف: | A randomized Phase II/III trial commenced in May 2014. Endoscopic balloon dilation with steroid injection is the current standard treatment for patients with refractory anastomotic stricture after esophagectomy. The purpose of this study is to confirm the superiority of radial incision and cutting with steroid injection in terms of both restricture-free survival and number of dilations within 24 weeks compared with endoscopic balloon dilation with steroid injection for these patients. A total of 130 patients will be accrued from 30 Japanese institutions over 3 years. The primary endpoint in the Phase II part is proportion of Grade 3/4 intraoperative hemorrhages, post-operative esophageal perforations, esophageal hemorrhages, pneumothorax, lung or mediastinum infections or other unexpected adverse events. Co-primary endpoints in the Phase III part are restricture-free survival and number of dilations within 24 weeks after treatment. Secondary endpoints are proportion of patients with anastomotic diameter >10 mm at 8 weeks after treatment, proportion of adverse events, proportion of patients experiencing improvement of dysphagia score at 2, 4, 8 and 24 weeks after treatment and proportion of patients with dysphagia score ≤1 at 24 weeks after treatment. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000014017 [http://www.umin.ac.jp/ctr/index.htm]. |
| تدمد: | 1465-3621 0368-2811 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fa898b2bb154f91f09b02fb77ba714c1 https://doi.org/10.1093/jjco/hyv006 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....fa898b2bb154f91f09b02fb77ba714c1 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14653621 03682811 |
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