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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018266
Receipt No. R000021142
Scientific Title A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)
Date of disclosure of the study information 2015/07/10
Last modified on 2018/01/10

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Basic information
Public title A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)
Acronym A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)
Scientific Title A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)
Scientific Title:Acronym A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)
Region
Japan

Condition
Condition Gastric epithelial neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To comfirm the superiority of dental floss-clip ESD to conventional ESD in terms of procedure time for patients with gastric epithelial neoplasia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes ESD procedure time
Key secondary outcomes ESD procedure time according to the proficiency of the operator (trainee or expert), the location of the lesion, the presence of ulcer findings and tumor size; self completion rate of ESD among beginners; procedure time of hemostasis; times of hemostasis; damage of specimen caused by dental floss-clip traction; en bloc resection rate; complete en bloc resection rate; serious adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A: Conventional ESD group
Interventions/Control_2 B: Dental floss-clip ESD group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric adenoma or cancer, which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline 2014.
2) ESD for one lesion.
3) No gastrectomy and no reconstructive surgery of gastric tube for esophageal cancer.
4) Aged 20 years old or more.
5) ECOG performance status of 0, 1 or 2.
6) The possibility of stenosis after ESD is low. All of the following conditions must be fulfilled:
i) Predicted line of mucosal incision is not on the EG junction.
ii) Predicted line of mucosal incision is not on the pylorus.
7) Adequate organ functions and all of the following conditions within 56 days at registration must be fulfilled:
i) Hb is no less than 9.0 g/dl,
ii)Plt is no less than 100,000 /mm3.
8) Follow up for 30 days after ESD.
9) Written informed consent.
Key exclusion criteria 1) Impossible to suspend anticoagulant or antiplatelet medications except low-dose aspirin.
2) Infectious disease with systemic therapy indicated.
3) Women during pregnancy or breast-feeding.
4) Severe psychiatric disease.
5) Systemic steroids medication.
6) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks.
7) Severe respiratory disease requiring continuous oxygen therapy.
8) Uncontrollable hypertension.
9) Uncontrollable diabetes millutus or administration of insulin.
Target sample size 640

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Takizawa
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-Gun, Shizuoka 411-8777, JAPAN
TEL 055-989-5222
Email k.takizawa@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masao Yoshida
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-Gun, Shizuoka 411-8777, JAPAN
TEL 055-989-5222
Homepage URL
Email ma.yoshida@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Shizuoka Cancer Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪府立病院機構大阪府立成人病センター(大阪府)
岡山大学医学部(岡山県)
がん研究会有明病院(東京都)
北里大学医学部(神奈川県)
埼玉医科大学国際医療センター(埼玉県)
国立病院機構四国がんセンター(愛媛県)
静岡県立静岡がんセンター(静岡県)
仙台オープン病院(宮城県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
東京大学医学部(東京都)
斗南病院(北海道)
福島県立医科大学(福島県)
由利組合総合病院(秋田県)
横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 21 Day
Last follow-up date
2016 Year 09 Month 04 Day
Date of closure to data entry
2016 Year 09 Month 11 Day
Date trial data considered complete
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 10 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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