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.
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.
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
- 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.
- 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.
- 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)
- 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.
- 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)
- 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.
METHOD
- 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.
- 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.
- 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)
- second TTT activity (2015 July -8 months),;
- 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)
- third TTT activity (2015 November -12 months);
- 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)
- fourth TTT activity (2016 February -3 months);
- 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)
- 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.
- Conditions
- Early Gastric Cancer
- 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 group | Role | What they receive |
|---|---|---|
| The control group | No intervention | no intervention |
| The experimental group | Experimental | an educational intervention Receives: Other: an educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao li-qing, MD, Principal investigator, Shanghai Zhongshan Hospital
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 21351269Suvakovic 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 9378383Kanesaka 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 25442093Mabe 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 24733047Yao 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 24407989Kanemitsu 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 24037102Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
PubMed 24714327Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02385578
- Acronym / sponsor ID
- B2015-048
- Conditions
- Early Gastric Cancer
- Keywords
- VS (vessel plus surface) classification system, Magnified endoscopy with narrow band imaging (ME-NBI), the rate of detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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)
- 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.
- 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.
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)
- 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.
METHOD
- 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.
- 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.
- 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)
- second TTT activity (2015 July -8 months),;
- 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)
- third TTT activity (2015 November -12 months);
- 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)
- fourth TTT activity (2016 February -3 months);
- 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)
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –no intervention |
| The experimental group | Experimental | Other: an educational interventionan educational intervention |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- ( 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an educational interventionAlso: 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 | Other | The experimental group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Results publication: PubMed 21351269Ferlay 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.
- Results publication: PubMed 9378383Suvakovic 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.
- Results publication: PubMed 25442093Kanesaka 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.
- Results publication: PubMed 24733047Mabe 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.
- Results publication: PubMed 24407989Yao 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.
- Results publication: PubMed 24037102Kanemitsu 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.
- Results publication: PubMed 24714327Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
- Results publication: PubMed 25590840Zhang 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.
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Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Active, not recruitingObservational study
Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8
RecruitingObservational study
Breath Research Narrow Validation for Gastrointestinal Cancer Detection
Oesophageal Squamous Cell Carcinoma, Oesophageal Adenocarcinoma
RecruitingObservational study
The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Gastric Neoplasms, Gastric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao li-qing, MD principal investigator
Shanghai Zhongshan Hospital
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.