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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024080
Receipt No. R000027625
Scientific Title A randomized controlled trial comparing conventional ESD versus ESD with countertraction for superficial esophageal cancer (CONNECT-E trial)
Date of disclosure of the study information 2016/09/16
Last modified on 2019/03/20

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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 Unpublished

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 No longer recruiting
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 03 Month 20 Day


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

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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