UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024080 |
|---|---|
| Receipt number | 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 | 2019/09/19 12:26:15 |
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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
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
ma.yoshida@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027625
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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