NCT02385578

Brief Summary

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. 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. 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. 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. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 11, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

February 28, 2015

Last Update Submit

March 10, 2015

Conditions

Keywords

VS (vessel plus surface) classification systemMagnified endoscopy with narrow band imaging (ME-NBI)the rate of detection

Outcome Measures

Primary Outcomes (1)

  • The rates of EGC detection

    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

Study Arms (2)

The control group

NO INTERVENTION

no intervention

The experimental group

EXPERIMENTAL

an educational intervention

Other: an educational intervention

Interventions

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

Also known as: the first step of the train the trainer plan(TTT)
The experimental group

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • ( 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

  • Suvakovic Z, Bramble MG, Jones R, Wilson C, Idle N, Ryott J. Improving the detection rate of early gastric cancer requires more than open access gastroscopy: a five year study. Gut. 1997 Sep;41(3):308-13. doi: 10.1136/gut.41.3.308.

  • Kanesaka T, Sekikawa A, Tsumura T, Maruo T, Osaki Y, Wakasa T, Shintaku M, Yao K. Absent microsurface pattern is characteristic of early gastric cancer of undifferentiated type: magnifying endoscopy with narrow-band imaging. Gastrointest Endosc. 2014 Dec;80(6):1194-1198.e1. doi: 10.1016/j.gie.2014.08.021. Epub 2014 Oct 16. No abstract available.

  • Mabe K, Yao K, Nojima M, Tanuma T, Kato M. An educational intervention to improve the endoscopist's ability to correctly diagnose small gastric lesions using magnifying endoscopy with narrow-band imaging. Ann Gastroenterol. 2014;27(2):149-155.

  • Yao K, Doyama H, Gotoda T, Ishikawa H, Nagahama T, Yokoi C, Oda I, Machida H, Uchita K, Tabuchi M. Diagnostic performance and limitations of magnifying narrow-band imaging in screening endoscopy of early gastric cancer: a prospective multicenter feasibility study. Gastric Cancer. 2014 Oct;17(4):669-79. doi: 10.1007/s10120-013-0332-0. Epub 2014 Jan 10.

  • Kanemitsu T, Yao K, Nagahama T, Fujiwara S, Takaki Y, Ono Y, Matsushima Y, Matsui T, Tanabe H, Ota A, Iwashita A. The vessels within epithelial circle (VEC) pattern as visualized by magnifying endoscopy with narrow-band imaging (ME-NBI) is a useful marker for the diagnosis of papillary adenocarcinoma: a case-controlled study. Gastric Cancer. 2014;17(3):469-77. doi: 10.1007/s10120-013-0295-1. Epub 2013 Sep 15.

  • Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.

  • Zhang Q, Chen ZY, Chen CD, Liu T, Tang XW, Ren YT, Huang SL, Cui XB, An SL, Xiao B, Bai Y, Liu SD, Jiang B, Zhi FC, Gong W. Training in early gastric cancer diagnosis improves the detection rate of early gastric cancer: an observational study in China. Medicine (Baltimore). 2015 Jan;94(2):e384. doi: 10.1097/MD.0000000000000384.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yao li-qing, MD

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SHI QIANG, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 11, 2015

Record last verified: 2015-02