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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025754
Receipt No. R000026835
Scientific Title Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial
Date of disclosure of the study information 2017/02/14
Last modified on 2019/08/09

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Basic information
Public title Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial
Acronym STAR trial
Scientific Title Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial
Scientific Title:Acronym STAR trial
Region
Japan

Condition
Condition large flat colorectal adenomas
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of the Tip-in EMR technique for large flat colorectal adenomas (15-25 mm in diameter) in randomized comparison with conventional EMR method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes En bloc resection rate in intention-to-treat analysis
Key secondary outcomes 1.En bloc resection rate in per-protocol analysis
2. Complete R0 resection rate
3. One-year accumulate recurrence rate
4. En bloc resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter)
5. One-year accumulate recurrence rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter)
6. Complete R0 resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter)
7. En bloc resection rate by lesion location
8. One-year accumulate recurrence rate in en bloc resection group and piecemeal resection group
9. One-year accumulate recurrence rate in R0 resection group and R1resection group
10. One-year accumulate recurrence rate in cases of RX resection
11. Rate of exclusion by poor lesion lifting in cases with previous biopsies
12. Complication rate
13. Accuracy of endoscopic diagnosis for residual adenomas during surveillance tests

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 not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 conventional EMR
Interventions/Control_2 Tip-in EMR technique
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. Patients with a large flat adenoma (15-25 mm in size)
2. Patients aged over 20 years old when consents to the participation is obtained
3. Ptients consented after full understanding of this study
Key exclusion criteria 1. Cases with clinical diagnosis of T1 cancer
2. Cases with difficulties to interrupt intake of anticoagulant drugs
3. Inappropriate cases by investigators
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kenichiro
Middle name
Last name Imai
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Email k.imai1977@gmail.com

Public contact
Name of contact person
1st name Kenichiro
Middle name
Last name Imai
Organization Shizuoka Cancer Center
Division name Division of Endoscopy
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Homepage URL
Email k.imai1977@gmail.com

Sponsor
Institute Division of Endoscopy, Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Division of Endoscopy, Shizuoka Cancer Center
Organization
Division
Category of Funding Organization Self funding
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 ke.imai@scchr.jp

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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 14 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
2017 Year 01 Month 17 Day
Date of IRB
2017 Year 01 Month 17 Day
Anticipated trial start date
2017 Year 01 Month 29 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 20 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026835

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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