the Train the Trainer (TTT) Plan, to Improve the Young Endoscopist's Ability to Find the Early Gastric Cancer

March 10, 2015 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

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. In addition, for early gastric cancer patients, it was record,(1) the patient's name, (2)gender, (3)age, (4)the location of the lesion- longitudinal (upper, middle and lower),(5) the location of the lesion -circumferential (lessor curvature, Greater curvature, anterior wall, posterior wall),(6) lesion size, (7)conventional white-light imaging (red, white, no change), (8)EM-NBI VS type (boundaries, microvascular pattern and microsurface pattern; don't do it), (9)microscopy types (uplift type, flat type, concave type or IIc I/IIa or IIb), (10)histological type (differentiated and undifferentiated type) and (11) pathological (low grade neoplasia, high-level neoplasia etc.). For the treatment of ESD patients, further pathological results were recorded after ESD, including the pathology, edge and basal conditions.

    Note:

    (A) those had been diagnosed outside the hospital before gastroscopy, withhold, listed separately.

    (B) for anesthesia, or not to determine whether anesthesia, withhold, separately listed; (C) considering the actual clinical situation, in the absence of pathological report, endoscopy reports generally will not report "early gastric cancer", but will use descriptive language diagnosis as "erosion" "apophysis" " ulcer". The investigators will find out the suspected early gastric cancer, then go on to confirm the diagnosis by the pathologic findings.

    (D) considering the actual clinical situation, the investigators often wrote the Malignant tumor （MT） instead of the gastric cancer in patients' report. Don't miss the descriptive language as "ulcer" patients. Found out the suspected patients and confirmed by pathology.

  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. Core: First, a detailed examination by white light is used to look for an irregular margin or a depressed spiny area.Then narrow-band imaging is used to look for a demarcation line, an microvascular pattern and microsurface pattern .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 (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)EM-NBI VS type (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 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. second TTT activity (2015 July -8 months),;
  5. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT content (for the T2 period),.The other five doctors do the gastroendoscopy as they do before. (300 cases / person)
  6. third TTT activity (2015 November -12 months);
  7. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT content (for the T3 period),The other five doctors do the gastroendoscopy as they do before. (300 cases / person)
  8. fourth TTT activity (2016 February -3 months);
  9. The five doctors who accepted the TTT do the gastroendoscopy in accordance with the TTT content (for the T4 period),The other five doctors do the gastroendoscopy as they do before. (300 cases / person)
  10. Statistics the number of early gastric cancer have been found by the five young doctors, and how mang gastroscopy they have done.

(A) List the general condition of patients before and after TTT; found the location of the tumor, whether the same type? (B) The rates of EGC detection before and after the TTT? Is the rates of Gastric cancer(GC) detection increasing? (C)The rates of EGC detection between the doctor accepted the TTT and not? (D) is the rates of EGC detection different among T1, T2, T3, T4 ? Is the rates of Gastric cancer detection increasing? (F) early cancer patients was found after TTT training, comparison the endoscopic diagnosis with Pathology, and pay attention to accuracy, sensitivity, false positive rate and false negative rate （ME-NBI）. And the reason analysis.

Study Type

Interventional

Enrollment (Anticipated)

16000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion 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 ( - 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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The control group
no intervention
Experimental: The experimental group
an educational intervention
Other: an educational intervention
the first step of the train the trainer plan(TTT) ,which including the diagnosis and operation "hand in hand" teach by Professor Yano Takeshiin,and the case discussion,and so on
Other Names:
  • the first step of the train the trainer plan(TTT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rates of EGC detection
Time Frame: 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
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Yao li-qing, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 28, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2015-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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