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临床试验/NCT01599351
NCT01599351已完成4 期

Different Radiation Exposures to Patient and Endoscopists Between Performing ERCP in Patients Lying Prone and Left Lateral Decubitus

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Patients' entrance surface dose

研究概览

简要总结

The objective of this study is to evaluate the radiation dose to patient at two positions (prone and left lateral) and to medical staff during Endoscopic retrograde cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20 patients at left lateral position.

详细描述

The radiographic-fluoroscopic system manufactured by Siemens Model POLYSTAR was used for ERCP procedure at King Chulalongkorn Memorial Hospital. Dose Area Product (DAP) manufactured by PTW Model DIAMENTOR E, a transmission ionization chamber was attached to X-ray collimator to record the dose-area (cGy.cm2) in order to determine the entrance surface air kerma (ESAK, mGy) of the patients at two positions (prone and left lateral) while the Kodak Portal Pack for localization imaging was placed on the patient's couch to determine the exposed area (cm2) on the surface of the patient. TLD was attached at five positions, left eye, thyroid, left forearm, lower abdomen and left leg of the medical staff during ERCP procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with common bile duct (CBD) stone and underwent ERCP
  • age over 18 years
  • ASA class I-II

排除标准

  • Abnormal coagulation
  • ASA class III-IV
  • Emergency/urgency conditions
  • Unstable vital signs
  • Denied to participate the study

结局指标

主要结局

Patients' entrance surface dose

时间窗: within 12 hours after procedure

Transparent ionization chamber was placed at the light beam diaphragm of the x-ray tube to measure the dose in the air and the verification film was placed on the couch at fluoroscopic area to determine exposed area. Patient's dose-area product will express in cGy.cm2.

次要结局

  • Endoscopists' radiation dose(Within 12 hours after procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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