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Early Gastric CancerNCT02385578

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

A study testing an educational intervention in people with Early Gastric Cancer, run by Shanghai Zhongshan Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. a retrospective analysis of the ten young endoscopist's painless gastroscopy examination from January 1, 2014 to December 31, 2014. Read more about this study

Who is it for?
Ages 17 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Early Gastric Cancer
What is being tested?
an educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16,000 participants
Where
No sites listed yet
Study dates
Mar 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • ( 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;
Show all 9Show fewer
  • 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. -

Trial locations and contacts

No sites are listed yet.

SHI QIANG, PhD contact

8613818853175

shiqiangqy@126.com

About this study

Official title: 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.
Read the 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.
Being tested
an educational intervention
Keywords
VS (vessel plus surface) classification system, Magnified endoscopy with narrow band imaging (ME-NBI), the rate of detection
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • an educational interventionOther

    Also called the first step of the train the trainer plan(TTT)

    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

Study groups in NCT02385578
Study groupRoleWhat they receive
The control groupNo interventionno intervention
The experimental groupExperimentalan educational intervention
Receives: Other: an educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385578
Sponsor's protocol ID
B2015-048
Status last verified
Feb 2015
First submitted
28 Feb 2015
Last updated
11 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21351269
  • 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.

    PubMed 9378383
  • 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.

    PubMed 25442093
  • 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.

    PubMed 24733047
  • 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.

    PubMed 24407989
  • 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.

    PubMed 24037102
  • Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.

    PubMed 24714327
  • 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.

    PubMed 25590840

Questions about this trial

What is this clinical trial studying?

A study testing an educational intervention in people with Early Gastric Cancer, run by Shanghai Zhongshan Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact SHI QIANG, PhD (8613818853175, shiqiangqy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rates of EGC detection (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385578, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.

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