UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial comparing conventional ESD versus ESD with dental floss-clip traction for gastric epithelial neoplasia (CONNECT-G trial)
Title of the study (Brief title)	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	Kohei Takizawa
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
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	Masao Yoshida
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021142