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临床试验/NCT04547881
NCT04547881已完成不适用

Prospective Assessment of the Gravity Assisted Technique for Esophageal Endoscopic

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Total time for lesion removal

研究概览

简要总结

This is a prospective data recording study, all patients will receive standard medical care and no experimental interventions will be performed. All patients scheduled to undergo esophageal ESD from December 2018 to December 2021 as medically indicated will be considered for the study, Patients in whom esophageal ESD is considered as part of their standard medical care will be offered to participate in this study. The principle investigator who performing the procedure will also discuss the study with the subjects and ask them to sign a consent. If the patient agrees to participate, he/she will be given the informed consent form and allowed enough time to read it. Then if the patient agrees, he/she will sign the consent form. Data will be prospectively recorded according to the data collection form.

详细描述

Early precancerous esophageal lesions and esophageal cancer, are a threatening illnesses with high mortality rate, so the early intervention is critical during the course of treatment, statistically, every year an estimated 17,290 adults in the United States will be diagnosed with esophageal cancer. Esophageal cancer is the seventh most common cause of cancer death among men (1, 2). Giving the aggressive nature and fatality of esophageal cancer, the early management using the Endoscopic submucosal dissection is very essential (3).

Esophageal ESD is a technique that grants the en-block resection of lesions, with less morbidity and mortality when compared to surgery, and more efficient than other endoscopic techniques like endoscopic mucosal resection as ESD associated with higher curative resection rates and lower recurrence rates (4). ESD require experience and excellent training due to technique difficulties, longer procedure times and possible serious adverse events.

The esophageal Endoscopic Submucosal Dissection (ESD) is gaining momentum in United States. Although a great deal of training is focused on teaching how to utilize the equipment for performing the procedure, the strategy of where to start the incision and how to proceed with dissection is not yet standardized. The investigators standardized a technique for performing esophageal ESD utilizing gravity as traction to expedite the procedure.

Currently, the investigators are performing this technique for esophageal ESD at Baylor St. Luke's Medical center.

The aim of the study is to assess the mean time needed to perform esophageal ESD using this technique. Our quality metrics are a dissection rate of 9cm2 per hour as suggested by Japanese experts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Scheduled to undergo esophageal ESD as part of their standard-of-care.

排除标准

  • Patients less than 18 years old.
  • Pregnant women
  • Patient is unable/unwilling to provide informed consent.

结局指标

主要结局

Total time for lesion removal

时间窗: 2 years

To assess the mean time needed to perform esophageal ESD using this technique.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Othman

M.D. Chief, Gastroenterology Section, BSLMC William T. Butler Endowed Chair for Distinguished Faculty Associate Professor of Medicine - Gastroenterology and Hepatology Section

Baylor College of Medicine

研究点 (1)

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