UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)
Acronym	A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)
Scientific Title	A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)
Scientific Title:Acronym	A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)
Region	Japan

Condition
Condition	superficial esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To comfirm the superiority of countertraction ESD to conventional ESD in terms of procedure time for patients with superficial esophageal cancer.
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 location of the lesion, the circumference, and tumor size; the rate of conversion case from conventional ESD to counter-traction ESD; procedure time of hemostasis; times of hemostasis; total quantity of injected solutions into the submucosa; damage of specimen caused by counter-traction; en bloc resection rate; complete en bloc resection rate; serious adverse events; factors related to technical difficulty

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: countertraction 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 squamous cell carcinoma or basal cell carcinoma, or endoscopically diagnosed as cancer based on the Japan esophageal society classification. 2) Tumor size of 20 mm or more. 3) Tumor depth of EP, LPM, MM or SM1. 4) Aged 20 years old or more. 5) ECOG performance status of 0, 1 or 2. 6) 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. 7) Written informed consent.
Key exclusion criteria	1) Treatment for gastric lesions the same day. 2) The predicted line of mucosal incision is on the previous esophageal ESD. 3) Stenosis due to the previous esophageal ESD. 4) Status after radiation or surgery for esophageal cancer. 5) Severe psychiatric disease. 6) Infectious disease with systemic therapy indicated. 7) Women during pregnancy or breastfeeding. 8) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks. 9) Unsuitable patient for clinical trial judged by clinicians' view.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Takizawa
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code	411-8777
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 Masao Middle name Last name Yoshida
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code	411-8777
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	Shizuoka Cancer Center
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel	055-989-5222
Email	irb@scchr.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	28-9-28-1-5
Org. issuing International ID_1	Shizuoka Cancer Center
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） 静岡県立静岡がんセンター（静岡県） 順天堂大学（東京都） 国立がん研究センター中央病院（東京都） 日本大学（東京都） 斗南病院（北海道） 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	2016 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/31445039
Number of participants that the trial has enrolled	241
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	2016 Year 07 Month 05 Day
Date of IRB	2016 Year 09 Month 06 Day
Anticipated trial start date	2016 Year 09 Month 16 Day
Last follow-up date	2019 Year 04 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 16 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027625