Submucosal Saline Injection Followed by Endoscopic Ultrasound versus Endoscopic Ultrasound Only for Distinguishing between T1a and T1b Esophageal Cancer: A Single-Blind, Superiority, Phase 3, Randomized Controlled Trial
| Autor: | Linna Luo, Yi-Tai Xiao, Guangyu Luo, Li Ming Chen, Shuo-Chun Zeng, Jian Jun Li, Longjun He, Chuanbo Xie, Rui-Hua Xu, Xiaoyan Gao, Yin Li, Hongbo Shan, Guo Liang Xu, Zi-Xian Wang, Ping Yang |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Endoscopic ultrasound
medicine.medical_specialty education.field_of_study medicine.diagnostic_test business.industry medicine.medical_treatment Population digestive system diseases Surgery law.invention Clinical trial Randomized controlled trial law Esophagectomy Clinical endpoint Medicine media_common.cataloged_instance European union Stage (cooking) business education media_common |
| Zdroj: | SSRN Electronic Journal. |
| ISSN: | 1556-5068 |
| DOI: | 10.2139/ssrn.3250937 |
| Popis: | Background: Traditional endoscopic ultrasound's (EUS) accuracy in distinguishing between T1a and T1b stage esophageal cancer (EC) is inadequate. As such, we examined whether submucosal saline injection (SSI) can improve its diagnostic accuracy. Methods: We conducted a randomized controlled phase 3 trial at Sun Yat-sen University Cancer Center. A total of 180 patients aged 18-85 years old with T1N0M0 stage EC indicated by prior EUS and radiologic imaging were enrolled and randomly assigned (1:1) to receive either EUS examination after SSI (EUS examination after 3-5 ml submucosal saline injection) or EUS only examination. The randomization sequence was computer-generated and no stratification factor was used. All the patients were referred to thoracic surgeons to receive endoscopic submucosal dissection (ESD) or esophagectomy within one week after EUS examination. Patients, research assistants, thoracic surgeons, pathologists, and statisticians were masked to the allocated examination. Standard EUS criteria were used to preoperatively stage the EC cases, while surgical pathology reports after referral were used to postoperatively stage the cases. The primary endpoint was the diagnostic accuracy of T1a staging (defined as the sum of the true positive [T1a] and true negative [T1b] cases divided by the total number of cases) analyzed in the per-protocol population. Findings: Between February 14, 2012 to October 23, 2017, 180 patients were enrolled and randomly assigned to receive SSI EUS (n=90) or EUS only (n=90) examination. Among the per-protocol population, the SSI EUS group (n=81) was superior to the EUS-only group (n=87) in terms of the diagnostic accuracy for T1a staging (86.4% [95% CI, 79.0-93.9] vs. 66.7% [95% CI, 56.8-76.6]; p=0.003). The specificities with SSI EUS and EUS-only were similar (92.3% [95% CI, 82.1-100.0] vs. 90.5% [95% CI, 81.6-99.4]; p>0.999), whereas the sensitivity of SSI EUS was significantly higher than EUS-only (83.6% [95% CI, 73.9-93.4] vs. 44.4% [95% CI, 29.9-59.0]; p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|