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临床试验/NCT02385578
NCT02385578Unknown不适用

An Educational Intervention, the First Step of the Train the Trainer (TTT) Plan, to Improve the Young Endoscopist's Ability to Find the Early Gastric Cancer:Prospective Study With Historical Control

Shanghai Zhongshan Hospital0 个研究点目标入组 16,000 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
16,000
主要终点
The rates of EGC detection

研究概览

简要总结

AIM Verified if the first stage of the Train the trainer (TTT)plan could improve the young endoscopist's ability to detect the early gastric cancer(EGC).

METHOD

  1. a retrospective analysis of the ten young endoscopist's painless gastroscopy examination from January 1, 2014 to December 31, 2014. According mainly to the endoscopic report and pateint's History, quantity of gastroscope, gastric cancer and the early gastric cancer.
  2. the first step of the train the trainer plan(TTT) activised in March 19-20,2015,which including the diagnosis and operation "hand in hand" teach by Professor Yano Takeshiin,and the case discussion,and so on. Five young endoscopist accepted the TTT plan and the other five not accepted.
  3. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT content (for the T1 period),.(1) the patient's name, (2)gender, (3)age,(4)past medical history (Helicobacter pylori<HP>, gastritis, gastric ulcer, oral drug operation, etc.),(5)gastroscope operation time,(6)the location of the lesion- longitudinal (upper, middle and lower),(7) the location of the lesion -circumferential (lessor curvature, Greater curvature, anterior wall, posterior wall),(8) lesion size, (9)conventional white-light imaging (red, white, no change), (10)magnifying endoscopy with narrow-band imaging (EM-NBI) microvascular and mirosurface pattern VS classification system(VSCS) (boundaries, microvascular pattern and microsurface pattern; don't do it), (11)microscopy types (uplift type, flat type, concave type or IIc I/IIa or IIb), (12)histological type (differentiated and undifferentiated type) and (13) pathological (low grade neoplasia, high-level neoplasia etc.). For the treatment of endoscopy submucosal dissection (ESD) patients, further pathological results were recorded after ESD, including the pathology, edge and basal conditions. The other five doctors do the gastroendoscopy as they do before. (300 cases / person)
  4. 2-4 TTT activity ;The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT content (for the T2-T4 period),.The other five doctors do the gastroendoscopy as they do before.
  5. Statistics the number of early gastric cancer have been found by the five young doctors, and how mang gastroscopy they have done.pay attention to The rates of EGC detection.

详细描述

AIM Verified if the first stage of the Train the trainer (TTT)plan could improve the young endoscopist's ability to detect the early gastric cancer.

GROUP The control group five young endoscopist not accepted the TTT The experimental group five young endoscopist accepted the TTT CRITERIA The entry criteria (A) retrospective part (1) The gastroscopy patients was operated by the ten doctors in 2014: (2) painless gastroscopy(intravenous anesthesia); (3) age: 18-70 years old; male or female (B): prospective part

(1) consistent with gastroscopy indications: (2) painless gastroscopy(intravenous anesthesia); (3) age: 18-70 years old; male or female (4) signed the informed consent.

Exclusion criteria ( retrospective part and prospective part)

  1. those patients who underwent gastrectomy
  2. the emergency gastroscopy, such as, esophageal foreign body, gastric foreign body, upper gastrointestinal hemorrhage. ;
  3. serious gastric hemorrhage or food residue that influence endoscopist's observation;
  4. those had been diagnosed outside the hospital before gastroscopy this time;
  5. those took oral anticoagulants and can't do biopsy examination;
  6. those were not suitable for endoscopic contraindication for endoscopic examination or endoscopic biopsy;
  7. do not fit into the experiment;
  8. don't do as the test plan demand.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (A) retrospective part (1) The gastroscopy patients was operated by the ten doctors in 2014: (2) painless gastroscopy(intravenous anesthesia) (3) age: 18-70 years old; male or female ( - prospective part
  • consistent with gastroscopy indications:
  • painless gastroscopy(intravenous anesthesia)
  • age: 18-70 years old; male or female
  • signed the informed consent.

排除标准

  • ( retrospective part and prospective part)
  • those patients who underwent gastrectomy
  • the emergency gastroscopy, such as, esophageal foreign body, gastric foreign body, upper gastrointestinal hemorrhage. ;
  • serious gastric hemorrhage or food residue that influence endoscopist's observation;
  • those had been diagnosed outside the hospital before gastroscopy this time;
  • those took oral anticoagulants and can't do biopsy examination;
  • those were not suitable for endoscopic contraindication for endoscopic examination or endoscopic biopsy;
  • do not fit into the experiment;
  • don't do as the test plan demand. -

结局指标

主要结局

The rates of EGC detection

时间窗: 16 months

The rates of EGC detection before and after the TTT in the experiment group or in the control group? The rates of EGC detection between the experiment group and the control group after TTT

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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